61. 自己免疫性溶血性貧血 Autoimmune hemolytic anemia Clinical trials / Disease details
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05757570 (ClinicalTrials.gov) | May 2023 | 24/2/2023 | An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias | A Phase 1b Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4) | Immune Thrombocytopenia;Idiopathic Thrombocytopenic Purpura;Warm Autoimmune Hemolytic Anemia;Cold Agglutinin Disease | Drug: povetacicept | Alpine Immune Sciences, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 42 | Phase 1 | NULL |
| 2 | EUCTR2022-001773-31-ES (EUCTR) | 14/02/2023 | 11/10/2022 | A study of efficacy and safety of ianalumab in previously treated patients with warm autoimmune haemolytic aneamia | A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA) - VAYHIA | warm autoimmune haemolytic anaemia (wAIHA) MedDRA version: 25.0;Level: LLT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Argentina;Singapore;Hungary;United States;Japan;United Kingdom;Malaysia;Thailand;Spain;India;China;Taiwan;Italy;Israel;Australia;France;Germany | ||
| 3 | NCT05221619 (ClinicalTrials.gov) | January 31, 2023 | 5/1/2022 | Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) | Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006 | Warm Autoimmune Hemolytic Anemia | Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Temporarily not available | N/A | N/A | All | NULL | ||
| 4 | NCT05676697 (ClinicalTrials.gov) | January 13, 2023 | 7/12/2022 | PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy | Safety and Efficacy Study of PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy | Autoimmune Hemolytic Anemia;Failure of Two Rounds of Treatment | Drug: Linperlisib | Institute of Hematology & Blood Diseases Hospital | YL-Pharma | Recruiting | 18 Years | N/A | All | 20 | Phase 1 | China |
| 5 | NCT05648968 (ClinicalTrials.gov) | December 30, 2022 | 23/11/2022 | A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-blind, Study to Assess Efficacy and Safety of Ianalumab (VAY736) Versus Placebo in Warm Autoimmune Hemolytic Anemia (wAIHA) Patients Who Failed at Least One Line of Treatment | Warm Autoimmune Hemolytic Anemia (wAIHA) | Biological: Ianalumab;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 90 | Phase 3 | Singapore |
| 6 | NCT05535933 (ClinicalTrials.gov) | September 2022 | 31/8/2022 | HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | A Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HMPL-523 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm Antibody Autoimmune Hemolytic Anemia | Drug: HMPL-523(300mg PO QD);Drug: Placebo | Hutchison Medipharma Limited | NULL | Not yet recruiting | 18 Years | 75 Years | All | 110 | Phase 2/Phase 3 | NULL |
| 7 | EUCTR2021-002844-66-DE (EUCTR) | 30/05/2022 | 20/09/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia (PATHWAY) - PATHWAY | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: Paraclisib Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 INN or Proposed INN: Paraclisib Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Japan;Ukraine;United Kingdom;Spain;Canada;Austria;Netherlands;Belgium;Poland;Italy;Israel;France;Germany | ||
| 8 | EUCTR2021-003160-27-HU (EUCTR) | 19/04/2022 | 23/02/2022 | A Randomized, Double-blind, Placebo-controlled Study to Evaluate Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)” | A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) | Patients with Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: APL-2 Product Name: PEGCETACOPLAN (APL-2) Product Code: 2019171-69-6 INN or Proposed INN: Pegcetacoplan | Swedish Orphan Biovitrum AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 9 | EUCTR2021-003160-27-ES (EUCTR) | 04/04/2022 | 05/04/2022 | A Randomized, Double-blind, Placebo-controlled Study to Evaluate Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)” | A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) | Patients with Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: APL-2 Product Name: PEGCETACOPLAN (APL-2) Product Code: 2019171-69-6 INN or Proposed INN: Pegcetacoplan | Swedish Orphan Biovitrum AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Canada;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 10 | NCT05073458 (ClinicalTrials.gov) | March 15, 2022 | 28/9/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia | Warm Autoimmune Hemolytic Anemia (wAIHA) | Drug: parsaclisinib;Drug: placebo | Incyte Corporation | NULL | Recruiting | 18 Years | 99 Years | All | 100 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom |
| 11 | EUCTR2021-002844-66-NL (EUCTR) | 10/03/2022 | 29/11/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Canada;Belgium;Poland;Netherlands;Germany;Japan | ||
| 12 | EUCTR2021-002039-40-IT (EUCTR) | 08/02/2022 | 01/10/2021 | Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disorders | An open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders - -- | Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: BEXSERO – Sospensione iniettabile – Siringa preriempita Product Name: - Product Code: [-] INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML Product Name: - Product Code: [-] INN or Proposed INN: VACCINO HAEMOPHILUS INFLUENZAE B CONIUGATO CON TOSSOIDETETANICO Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: Nimenrix Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Korea, Democratic People's Republic of;Germany;United Kingdom;Italy | ||
| 13 | EUCTR2021-002844-66-ES (EUCTR) | 03/02/2022 | 15/10/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: INCB050465 INN or Proposed INN: Parsaclisib Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: INCB050465 INN or Proposed INN: Parsaclisib Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;Japan | ||
| 14 | NCT04956276 (ClinicalTrials.gov) | January 1, 2022 | 30/6/2021 | Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia | A Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA) | Warm Autoimmune Hemolytic Anemia | Drug: ALXN1830;Drug: Placebo | Alexion Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 15 | JPRN-jRCT2051210140 | 30/12/2021 | 24/12/2021 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia - PATHWAY | Warm Autoimmune Hemolytic Anemia (wAIHA) | Group A: Parsaclisib (INCB050465) will be administered QD orally. Group B: Placebo will be administered QD orally. | Ueda Eiji | NULL | Recruiting | >= 18age old | <= 99age old | Both | 100 | Phase 3 | U.S.A;Japan |
| 16 | NCT05086744 (ClinicalTrials.gov) | December 21, 2021 | 28/9/2021 | Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders | An Open-label, Multi-center, Phase 2 Basket Study to Assess Efficacy, Safety and Pharmacokinetics of Iptacopan (LNP023) in Participants With Autoimmune Benign Hematological Disorders | Immune Thrombocytopenia (ITP);Cold Agglutinin Disease (CAD) | Drug: Iptacopan | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States;Germany;Italy;Korea, Republic of;Spain;United Kingdom |
| 17 | JPRN-jRCT2031210392 | 07/12/2021 | 27/10/2021 | Sutimlimab (BIVV009) for the adult participants with cold agglutinin disease (CAD) who have completed Phase 3 studies (CARDINAL or CADENZA) in Japan | An open-label study for sutimlimab in participants with cold agglutinin disease (CAD) who have completed the CARDINAL study (BIVV009-03/EFC16215, Part B) or CADENZA study (BIVV009-04/EFC16216, Part B) in Japan | Cold Agglutinin Disease | Drug: sutimlimab (BIVV009) Pharmaceutical Form: solution for injection, Route of Administration: intravenous(iv) | Tanaka Tomoyuki | NULL | Not Recruiting | >= 20age old | Not applicable | Both | 7 | Phase 3 | Japan |
| 18 | NCT05002777 (ClinicalTrials.gov) | December 7, 2021 | 5/8/2021 | Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) | A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia | Warm Autoimmune Hemolytic Anemia (wAIHA) | Drug: rilzabrutinib | Sanofi | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States;China;Denmark;Italy;Spain;United Kingdom |
| 19 | EUCTR2021-002844-66-IT (EUCTR) | 23/11/2021 | 23/09/2021 | Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia - NA | Primary Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Parsaclisib (1 mg) Product Code: [INCB050465] Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: Parsaclisib (2.5 mg) Product Code: [INCB050465] Other descriptive name: INCB050465 HYDROCHLORIDE Product Name: trimethoprim-sulfamethoxazole Product Code: [trimethoprim-sulfamethoxazole] INN or Proposed INN: TRIMETOPRIM + SULFAMETOSSAZOLO * Product Name: pentamidine Product Code: [pentamidine] INN or Proposed INN: PENTAMIDINA ISETIONATO Product Name: atovaquone Product Code: [atovaquone] INN or Proposed INN: ATOVAQUONE | INCYTE CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;Japan | ||
| 20 | EUCTR2021-001671-16-DK (EUCTR) | 15/11/2021 | 16/07/2021 | Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia | A multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia | Warm autoimmune hemolytic anemia MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rilzabrutinib Product Code: SAR444671 INN or Proposed INN: Rilzabrutinib Other descriptive name: PRN1008 | Sanofi aventis recherche et developpement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | France;United States;Hungary;Spain;Austria;Denmark;Germany;United Kingdom;Italy;China | ||
| 21 | NCT05132127 (ClinicalTrials.gov) | November 11, 2021 | 11/11/2021 | Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan | An Open-label Study for Sutimlimab in Participants With Cold Agglutinin Disease (CAD) Who Have Completed the CARDINAL Study (BIVV009-03/EFC16215, Part B) or CADENZA Study (BIVV009-04/EFC16216, Part B) in Japan | Cold Agglutinin Disease | Drug: sutimlimab | Sanofi | NULL | Completed | 20 Years | N/A | All | 7 | Phase 3 | Japan |
| 22 | NCT04691570 (ClinicalTrials.gov) | November 10, 2021 | 28/12/2020 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Intravenous ANX005 in Subjects With Warm Autoimmune Hemolytic Anemia (wAIHA) | Warm Autoimmune Hemolytic Anemia (wAIHA) | Drug: ANX005 | Annexon, Inc. | NULL | Completed | 18 Years | N/A | All | 6 | Phase 2 | United States |
| 23 | EUCTR2021-002039-40-ES (EUCTR) | 02/11/2021 | 03/11/2021 | Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disorders | An open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders | Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 24 | EUCTR2021-002039-40-DE (EUCTR) | 29/10/2021 | 14/09/2021 | Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disorders | An open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders | Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 25 | EUCTR2020-003675-18-BG (EUCTR) | 28/10/2021 | 29/07/2021 | Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHA | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia | Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: ANX005 | Annexon, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;France;Czechia;Spain;Austria;Australia;Bulgaria;Germany;Italy | ||
| 26 | NCT05057468 (ClinicalTrials.gov) | October 20, 2021 | 16/9/2021 | Second-line Treatment of Primary Autoimmune Hemolytic Anemia | Cyclosporine as a Second-line Treatment of Primary Autoimmune Hemolytic Anemia | Primary Autoimmune Hemolytic Anemia | Drug: Cyclosporine;Drug: Rituximab | Assiut University | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 3 | Egypt |
| 27 | EUCTR2021-001671-16-ES (EUCTR) | 08/10/2021 | 23/06/2021 | Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia | A multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia | Warm autoimmune hemolytic anemia MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rilzabrutinib Product Code: SAR444671 INN or Proposed INN: Rilzabrutinib Other descriptive name: PRN1008 | Sanofi aventis recherche et developpement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | United States;Spain;Denmark;United Kingdom;Italy;China | ||
| 28 | NCT05263817 (ClinicalTrials.gov) | October 8, 2021 | 1/12/2021 | A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis | A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis | POEMS Syndrome;Amyloidosis;Autoimmune Hemolytic Anemia;Vasculitis | Biological: CD19/BCMA CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 75 | Early Phase 1 | China |
| 29 | EUCTR2021-001671-16-IT (EUCTR) | 24/09/2021 | 12/10/2021 | Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warmautoimmune hemolytic anemia | A multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia - . | Warm autoimmune hemolytic anemia MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rilzabrutinib Product Code: [SAR444671] INN or Proposed INN: Rilzabrutinib Other descriptive name: PRN1008 | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | United States;Spain;Denmark;United Kingdom;China;Italy | ||
| 30 | NCT05057481 (ClinicalTrials.gov) | September 15, 2021 | 16/9/2021 | Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus | Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus | Autoimmune Hemolytic Anemia;Systemic Lupus Erythematosus | Drug: Mycophenolate Mofetil 500mg;Drug: Rituximab | Assiut University | NULL | Active, not recruiting | 18 Years | N/A | All | 30 | Phase 3 | Egypt |
| 31 | NCT04661033 (ClinicalTrials.gov) | September 9, 2021 | 1/12/2020 | Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA) | A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia | Warm Autoimmune Hemolytic Anemia (wAIHA) | Drug: Isatuximab SAR650984 | Sanofi | NULL | Active, not recruiting | 18 Years | N/A | All | 8 | Phase 1/Phase 2 | United States;Belgium;France;Germany;Hungary;Italy;Netherlands;United Kingdom |
| 32 | EUCTR2021-001211-90-IT (EUCTR) | 26/08/2021 | 22/10/2021 | ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia | A Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo- Controlled Study of ALXN1830 Administered Subcutaneously in Patients with Warm Autoimmune Hemolytic Anemia (WAIHA) - N/A | Warm Autoimmune Hemolytic Anemia (WAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALXN1830 Product Code: [N/A] INN or Proposed INN: ORILANOLIMAB | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 33 | EUCTR2021-001211-90-ES (EUCTR) | 11/08/2021 | 02/07/2021 | ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia | A Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients with Warm Autoimmune Hemolytic Anemia (WAIHA) | Warm Autoimmune Hemolytic Anemia (WAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALXN1830 INN or Proposed INN: ORILANOLIMAB Other descriptive name: SYNT001 | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 34 | NCT04256148 (ClinicalTrials.gov) | July 2021 | 27/1/2020 | ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia | Warm Autoimmune Hemolytic Anemia | Biological: ALXN1830;Other: Placebo | Alexion Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 35 | EUCTR2020-003880-24-NL (EUCTR) | 09/06/2021 | 03/02/2021 | Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | Warm autoimmune hemolytic anemia MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Isatuximab Product Code: SAR650984 INN or Proposed INN: Isatuximab Other descriptive name: SAR650984 | Sanofi-Aventis Recherche & Developpement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 1;Phase 2 | France;United States;Hungary;Belgium;Germany;Netherlands;United Kingdom;Italy | ||
| 36 | EUCTR2020-003880-24-IT (EUCTR) | 07/06/2021 | 04/06/2021 | Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia - . | Warm autoimmune hemolytic anemia MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Montelukast Product Code: [.] INN or Proposed INN: MONTELUKAST Product Name: Isatuximab Product Code: [SAR650984] INN or Proposed INN: Isatuximab Product Name: Paracetamolo Product Code: [.] INN or Proposed INN: PARACETAMOLO Product Name: Famotidina Product Code: [.] INN or Proposed INN: FAMOTIDINA Product Name: Levocitirizina Product Code: [.] INN or Proposed INN: LEVOCETIRIZINA DICLORIDRATO | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 1;Phase 2 | France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 37 | ChiCTR2100045594 | 2021-04-19 | 2021-04-19 | A single center prospective clinical study of Orelabrutinib in the treatment of relapsed/refractory autoimmune hemolytic anemia/Evans syndrome | A single center prospective clinical study of Orelabrutinib in the treatment of recurrent refractory autoimmune hemolytic anemia/Evans syndrome | Relapsed/refractory autoimmune hemolytic anemia /Evans syndrome | Single arm:Orelabrutinib; | Tianjin Medical University General Hospital | NULL | Recruiting | Both | Single arm:20; | Phase 4 | China | ||
| 38 | EUCTR2019-001882-34-NL (EUCTR) | 06/04/2021 | 05/01/2021 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Bulgaria;Georgia;Norway;Germany;Netherlands | ||
| 39 | EUCTR2020-003880-24-DE (EUCTR) | 24/03/2021 | 14/12/2020 | Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmunehemolytic anemia | A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | Warm autoimmune hemolytic anemia MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Isatuximab Product Code: SAR650984 INN or Proposed INN: Isatuximab Other descriptive name: SAR650984 | Sanofi-Aventis Recherche & Developpement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 1;Phase 2 | France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 40 | NCT04802057 (ClinicalTrials.gov) | March 22, 2021 | 15/3/2021 | Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088 | An Open-label, Long-term, Safety and Tolerability Study of SAR445088 in Participants With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088 | Autoimmune Haemolytic Anaemia | Drug: SAR445088 | Bioverativ, a Sanofi company | NULL | Active, not recruiting | 18 Years | N/A | All | 9 | Phase 1 | Germany;Italy;Netherlands;Norway;United Kingdom |
| 41 | EUCTR2020-003880-24-HU (EUCTR) | 18/03/2021 | 28/01/2021 | Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | Warm autoimmune hemolytic anemia MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Isatuximab Product Code: SAR650984 INN or Proposed INN: Isatuximab Other descriptive name: SAR650984 | Sanofi-Aventis Recherche & Developpement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 1;Phase 2 | France;United States;Hungary;Belgium;Germany;Netherlands;United Kingdom;Italy | ||
| 42 | NCT04657094 (ClinicalTrials.gov) | March 16, 2021 | 1/12/2020 | Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia | A Phase 2 Trial of Acalabrutinib for the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia;Chronic Lymphocytic Leukemia;Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma;Warm Antibody Autoimmune Hemolytic Anemia | Drug: Acalabrutinib | City of Hope Medical Center | National Cancer Institute (NCI) | Active, not recruiting | 18 Years | N/A | All | 4 | Phase 2 | United States |
| 43 | EUCTR2020-005854-90-AT (EUCTR) | 11/02/2021 | 05/01/2021 | Investigation of the influence of ANX005 on the body of patients with primary cold agglutinin disease in terms of safety and tolerability. A Phase 2, single-center, open-label, repeat-dose study. | A Phase 2, Single-Center, Open-Label, Repeat-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Intravenous ANX005 in Participants with Primary Cold Agglutinin Disease | Primary Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: Recombinant humanized IgG4 monoclonal antibody | Annexon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Austria | ||
| 44 | EUCTR2020-003675-18-AT (EUCTR) | 05/02/2021 | 10/12/2020 | Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHA | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia | Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: ANX005 | Annexon, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Czechia;Spain;Australia;Austria;Bulgaria;Germany;United Kingdom;Italy | ||
| 45 | EUCTR2020-003675-18-DE (EUCTR) | 11/01/2021 | 28/09/2020 | Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHA | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia | Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: ANX005 | Annexon, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;United States;Czechia;Spain;Austria;Australia;Bulgaria;Germany;Italy | ||
| 46 | EUCTR2019-003924-19-BG (EUCTR) | 29/12/2020 | 23/09/2020 | Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia | A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA | Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RVT-1401 Product Code: RVT-1401 INN or Proposed INN: RVT-1401 Other descriptive name: RVT-1401 | Immunovant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | United States;Hungary;Poland;Spain;Thailand;Israel;Bulgaria;United Kingdom;Korea, Republic of | ||
| 47 | EUCTR2020-003675-18-IT (EUCTR) | 11/12/2020 | 02/08/2021 | Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHA | A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia - Study with intravenous ANX005 in patients with wAIHA | warm autoimmune hemolytic anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ANX005 Product Code: [ANX005] Other descriptive name: Recombinant humanized monoclonal antibody: IgG4 (heavy chain); kappa (light chain) | Annexon, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | France;Hungary;Spain;Austria;Norway;Netherlands;Germany;United Kingdom;Italy | ||
| 48 | EUCTR2019-003924-19-PL (EUCTR) | 04/11/2020 | 25/08/2020 | Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia | A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA | Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RVT-1401 Product Code: RVT-1401 INN or Proposed INN: RVT-1401 Other descriptive name: RVT-1401 | Immunovant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Bulgaria;Israel;United Kingdom;Korea, Republic of;United States;Hungary;Thailand;Spain;Poland | ||
| 49 | EUCTR2019-003924-19-HU (EUCTR) | 07/10/2020 | 17/08/2020 | Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia | A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA | Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RVT-1401 Product Code: RVT-1401 INN or Proposed INN: RVT-1401 Other descriptive name: RVT-1401 | Immunovant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | United States;Hungary;Poland;Thailand;Spain;Bulgaria;Israel;United Kingdom;Korea, Republic of | ||
| 50 | EUCTR2018-004774-97-RO (EUCTR) | 25/08/2020 | 21/03/2022 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Netherlands;Norway;Germany | ||
| 51 | EUCTR2019-001882-34-DE (EUCTR) | 23/07/2020 | 13/01/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 52 | NCT04039477 (ClinicalTrials.gov) | July 2020 | 26/7/2019 | A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP | A Phase 2 Randomized, Dose-blind, Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP) | Autoimmune Hemolytic Anemia;Immune Thrombocytopenia | Drug: KZR-616 | Kezar Life Sciences, Inc. | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States;Australia;Italy;Poland;Russian Federation |
| 53 | NCT04269551 (ClinicalTrials.gov) | June 15, 2020 | 29/1/2020 | A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease | A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease | Autoimmune Haemolytic Anaemia | Drug: BIVV020 | Bioverativ, a Sanofi company | NULL | Completed | 18 Years | N/A | All | 12 | Phase 1 | United States;Germany;Italy;Netherlands;Norway;United Kingdom;Canada;Spain |
| 54 | EUCTR2019-001882-34-DK (EUCTR) | 03/06/2020 | 20/01/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 55 | EUCTR2019-003924-19-ES (EUCTR) | 25/05/2020 | 14/01/2020 | Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia | A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA | Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RVT-1401 Product Code: RVT-1401 INN or Proposed INN: RVT-1401 Other descriptive name: RVT-1401 | Immunovant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | United States;Hungary;Poland;Thailand;Spain;Romania;Bulgaria;Israel;United Kingdom;Korea, Republic of | ||
| 56 | EUCTR2019-001882-34-IT (EUCTR) | 19/05/2020 | 30/07/2021 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia - C-935788-058 | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: [R935788] INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: [R935788] INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | RIGEL PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | Belarus;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 57 | EUCTR2019-004055-37-ES (EUCTR) | 06/05/2020 | 10/05/2020 | ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia | WAIHA MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ALXN1830 INN or Proposed INN: ORILANOLIMAB Other descriptive name: SYNT001 | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Korea, Republic of | ||
| 58 | EUCTR2019-001882-34-FR (EUCTR) | 05/05/2020 | 06/02/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 59 | NCT04398459 (ClinicalTrials.gov) | May 1, 2020 | 18/5/2020 | The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia | A Phase II, Multicenter, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic | Refractory/Relapsed Autoimmune Hemolytic Anemia | Drug: Ibrutinib | Institute of Hematology & Blood Diseases Hospital | NULL | Recruiting | 6 Years | 70 Years | All | 18 | Phase 2 | China |
| 60 | EUCTR2018-004774-97-NL (EUCTR) | 09/04/2020 | 09/10/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | Serbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Germany;Netherlands | ||
| 61 | EUCTR2019-000720-17-NL (EUCTR) | 31/03/2020 | 16/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Netherlands;Germany | ||
| 62 | EUCTR2019-003924-19-GB (EUCTR) | 26/02/2020 | 13/03/2020 | Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia | A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA | Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RVT-1401 Product Code: RVT-1401 INN or Proposed INN: RVT-1401 Other descriptive name: RVT-1401 | Immunovant Sciences GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 2 | United States;Thailand;Spain;Romania;Israel;United Kingdom;Korea, Republic of | ||
| 63 | EUCTR2019-001882-34-HU (EUCTR) | 25/02/2020 | 27/02/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 64 | EUCTR2019-001882-34-AT (EUCTR) | 24/02/2020 | 15/01/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Bulgaria;Georgia;Germany;Netherlands;Norway | ||
| 65 | EUCTR2019-001882-34-CZ (EUCTR) | 30/01/2020 | 20/12/2019 | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Georgia;Bulgaria;Norway;Germany;Netherlands | ||
| 66 | EUCTR2019-001882-34-ES (EUCTR) | 28/01/2020 | 02/12/2019 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 67 | EUCTR2019-001882-34-GB (EUCTR) | 20/01/2020 | 10/12/2019 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 68 | EUCTR2019-000720-17-DE (EUCTR) | 14/01/2020 | 05/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 69 | EUCTR2019-000720-17-GR (EUCTR) | 27/12/2019 | 08/10/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 70 | EUCTR2018-004774-97-DK (EUCTR) | 15/11/2019 | 20/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Norway;Netherlands;Germany;Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria | ||
| 71 | EUCTR2019-000720-17-HU (EUCTR) | 05/11/2019 | 06/11/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10073784;Term: Anemia hemolytic autoimmune;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 72 | NCT04138927 (ClinicalTrials.gov) | October 30, 2019 | 23/10/2019 | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm Antibody Autoimmune Hemolytic Anemia | Drug: Fostamatinib disodium | Rigel Pharmaceuticals | NULL | Enrolling by invitation | 18 Years | 100 Years | All | 90 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bulgaria;Czechia;France;Georgia;Germany;Italy;Netherlands;Norway;Russian Federation;Serbia;Spain;Ukraine;United Kingdom |
| 73 | NCT04119050 (ClinicalTrials.gov) | October 24, 2019 | 18/9/2019 | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension | Warm Autoimmune Hemolytic Anemia | Drug: M281;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 111 | Phase 2/Phase 3 | United States;Brazil;Canada;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Spain;Ukraine;United Kingdom |
| 74 | EUCTR2018-004774-97-GB (EUCTR) | 23/10/2019 | 04/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 75 | EUCTR2018-004774-97-IT (EUCTR) | 16/10/2019 | 22/01/2021 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia - C-935788-057 | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: na Product Name: Fostamatinib Disodium Product Code: [R935788] INN or Proposed INN: Fostamatinib Product Name: Fostamatinib Disodium Product Code: [R935788] INN or Proposed INN: Fostamatinib | RIGEL PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 76 | EUCTR2019-000720-17-FR (EUCTR) | 15/10/2019 | 17/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | Netherlands;Germany;United Kingdom;Italy;United States;France;Hungary;Czech Republic;Greece;Spain;Poland;Denmark | ||
| 77 | EUCTR2018-004774-97-DE (EUCTR) | 10/10/2019 | 26/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Netherlands;Norway;Germany | ||
| 78 | EUCTR2019-000720-17-PL (EUCTR) | 09/10/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: Not Applicable Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 79 | EUCTR2018-004774-97-BE (EUCTR) | 30/09/2019 | 09/08/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Netherlands;Norway;Germany | ||
| 80 | EUCTR2018-004774-97-AT (EUCTR) | 27/09/2019 | 27/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Serbia;United States;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 81 | EUCTR2019-000720-17-ES (EUCTR) | 19/09/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281 | Momenta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | France;United States;Hungary;Czech Republic;Greece;Poland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 82 | EUCTR2019-000720-17-IT (EUCTR) | 16/09/2019 | 27/01/2021 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study with a Long-term Open-label Extension - --- | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: M281 Product Code: [M281] INN or Proposed INN: M281 Other descriptive name: M281 | MOMENTA PHARMACEUTICALS, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 83 | EUCTR2019-000720-17-CZ (EUCTR) | 10/09/2019 | 10/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: N/A Other descriptive name: Nipocalimab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 2;Phase 3 | Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands;United States;Czechia;Greece;Spain | ||
| 84 | EUCTR2018-004774-97-ES (EUCTR) | 09/09/2019 | 11/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 85 | EUCTR2018-004774-97-CZ (EUCTR) | 05/09/2019 | 13/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 86 | EUCTR2018-004774-97-BG (EUCTR) | 05/09/2019 | 04/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Netherlands;Norway;Germany | ||
| 87 | NCT03965624 (ClinicalTrials.gov) | September 1, 2019 | 24/5/2019 | Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia | A Prospective Open-label Trial to Assess the Efficacy and Safety of Ixazomib and Dexamethasone in Patients With Refractory Autoimmune Cytopenia | Immune Thrombocytopenia;Warm Autoimmune Hemolytic Anemia | Drug: Ninlaro | Assistance Publique - Hôpitaux de Paris | Takeda Pharmaceuticals International, Inc. | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | France |
| 88 | NCT04083014 (ClinicalTrials.gov) | August 20, 2019 | 31/8/2019 | Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia | An Open, One-arm, Prospective Study of a Single Dose Anti-CD20 Monoclonal Antibody Combined With Bortezomib for Treatment of Relapsed Refractory Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia;Autoimmune Hemolytic Anemia and Autoimmune Thrombocytopenia | Drug: combination of a single dose anti-CD20 antibody and bortezomib | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 43 | Phase 2 | China |
| 89 | EUCTR2018-004774-97-HU (EUCTR) | 06/08/2019 | 17/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 90 | ChiCTR1900023476 | 2019-07-01 | 2019-05-30 | Multicenter, prospective and open clinical study for rapamycin in the treatment of autoimmune hemolytic anemia | Multicenter, prospective and open clinical study for rapamycin in the treatment of autoimmune hemolytic anemia | Autoimmune | 1:glucocorticoid;2:glucocorticoid & Ciclosporin;3:glucocorticoid & rapamycin;4:rapamycin; | Tianjin Medical University General Hospital | NULL | Pending | Both | 1:20;2:20;3:20;4:20; | China | |||
| 91 | NCT03912129 (ClinicalTrials.gov) | May 6, 2019 | 9/4/2019 | Autoimmune Cytopenia: Genetics and Pathophysiological Mechanism in Pediatric Evans Syndrome | Autoimmune Cytopenia: Genetics and Pathophysiological Mechanism in Pediatric Evans Syndrome | Evans Syndrome | Genetic: blood sample | University Hospital, Bordeaux | Institut des maladies génétiques, Paris | Not yet recruiting | N/A | N/A | All | 200 | N/A | NULL |
| 92 | NCT03918265 (ClinicalTrials.gov) | May 4, 2019 | 16/4/2019 | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Autoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans Syndrome | Drug: Tacrolimus | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 80 | Phase 4 | China |
| 93 | NCT03764618 (ClinicalTrials.gov) | April 24, 2019 | 3/12/2018 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm Antibody Autoimmune Hemolytic Anemia | Drug: Fostamatinib disodium;Drug: Placebo | Rigel Pharmaceuticals | NULL | Completed | 18 Years | 100 Years | All | 90 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom |
| 94 | NCT04005638 (ClinicalTrials.gov) | February 2, 2019 | 17/6/2019 | Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia | Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia | Immune Thrombocytopenia;Autoimmune Hemolytic Anemia;Autoimmune Neutropenia | Biological: blood sample;Biological: urine sample | University Hospital, Bordeaux | Ministry for Health and Solidarity, France | Recruiting | 18 Years | N/A | All | 200 | France | |
| 95 | NCT03538041 (ClinicalTrials.gov) | November 21, 2018 | 15/5/2018 | A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia | Drug: Parsaclisib | Incyte Corporation | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States;Austria;France;Italy |
| 96 | EUCTR2017-003652-22-IT (EUCTR) | 18/09/2018 | 15/01/2021 | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia - A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia.Warm AIHA, Cold AIHA MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: INCB050465 2.5 mg Product Code: [INCB050465 2.5 mg] Product Name: INCB050465 1 mg Product Code: [INCB050465 1 mg] | INCYTE CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | France;United States;Austria;Italy | ||
| 97 | EUCTR2017-003539-12-NL (EUCTR) | 03/09/2018 | 19/12/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand | ||
| 98 | EUCTR2017-003538-10-NL (EUCTR) | 03/09/2018 | 18/12/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR | Bioverativ USA, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan | ||
| 99 | EUCTR2017-003652-22-AT (EUCTR) | 18/07/2018 | 29/03/2018 | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) | A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia.Warm AIHA, Cold AIHA MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: INCB050465 1 mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE Product Code: INCB050465 2.5 mg INN or Proposed INN: not yet assigned Other descriptive name: INCB050465 HYDROCHLORIDE | Incyte Coorporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | France;United States;Austria;Italy | ||
| 100 | EUCTR2017-003363-35-IT (EUCTR) | 05/07/2018 | 04/11/2020 | Clinical study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | An open label, prospective, study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD). - Treatment of wAIHA with APL-2 | Patients affected by Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) MedDRA version: 20.0;Level: LLT;Classification code 10002045;Term: Anaemia haemolytic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: APL-2 Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: APL-2 | APELLIS PHARMACEUTCIALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | United States;Italy | ||
| 101 | EUCTR2017-003539-12-IT (EUCTR) | 19/03/2018 | 15/01/2021 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of bloodtransfusions | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | BIOVERATIV THERAPEUTICS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 102 | NCT03347422 (ClinicalTrials.gov) | March 17, 2018 | 16/11/2017 | A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion | Cold Agglutinin Disease | Drug: sutimlimab (BIVV009);Drug: placebo | Bioverativ, a Sanofi company | NULL | Completed | 18 Years | N/A | All | 42 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom |
| 103 | EUCTR2017-003538-10-IT (EUCTR) | 07/03/2018 | 28/01/2021 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLDAGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 INN or Proposed INN: BIVV009 | BIOVERATIV THERAPEUTICS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand | ||
| 104 | NCT03347396 (ClinicalTrials.gov) | March 5, 2018 | 16/11/2017 | A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study) | A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion | Agglutinin Disease, Cold | Drug: Sutimlimab | Bioverativ, a Sanofi company | NULL | Completed | 18 Years | N/A | All | 20 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom |
| 105 | EUCTR2017-003539-12-GB (EUCTR) | 26/02/2018 | 23/10/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 106 | EUCTR2017-003538-10-GB (EUCTR) | 26/02/2018 | 23/10/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ a Sanofi Company Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Japan | ||
| 107 | EUCTR2017-003538-10-DE (EUCTR) | 15/02/2018 | 30/10/2017 | A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;New Zealand | ||
| 108 | EUCTR2017-003539-12-DE (EUCTR) | 15/02/2018 | 30/10/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 109 | EUCTR2017-003539-12-ES (EUCTR) | 06/02/2018 | 07/11/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR | Bioverativ USA Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Japan;United States;Spain;Austria | ||
| 110 | EUCTR2017-003538-10-BE (EUCTR) | 26/01/2018 | 06/12/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand | ||
| 111 | EUCTR2017-003539-12-BE (EUCTR) | 26/01/2018 | 06/12/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand | ||
| 112 | EUCTR2017-003538-10-ES (EUCTR) | 19/01/2018 | 07/11/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan | ||
| 113 | NCT03075878 (ClinicalTrials.gov) | January 10, 2018 | 3/3/2017 | A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA) | A Phase 1B/2, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA) | Warm Autoimmune Hemolytic Anemia | Drug: ALXN1830 | Alexion Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 8 | Phase 1/Phase 2 | United States;Jordan |
| 114 | EUCTR2017-003538-10-NO (EUCTR) | 18/12/2017 | 02/11/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ a Sanofi Company Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Norway;Germany;Netherlands;Japan;New Zealand | ||
| 115 | EUCTR2017-003538-10-AT (EUCTR) | 15/11/2017 | 10/10/2017 | A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand | ||
| 116 | EUCTR2017-003539-12-AT (EUCTR) | 15/11/2017 | 10/10/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand | ||
| 117 | NCT03226678 (ClinicalTrials.gov) | August 31, 2017 | 7/7/2017 | Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | An Open Label, Prospective, Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | Warm Autoimmune Hemolytic Anemia;Cold Agglutinin Disease | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States |
| 118 | NCT02389231 (ClinicalTrials.gov) | May 17, 2017 | 13/2/2015 | Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment | Anemil Trial : Phase I/II Clinical Trial Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment | Autoimmune Hemolytic Anemia | Drug: Interleukine-2 | University Hospital, Bordeaux | NULL | Completed | 18 Years | N/A | All | 2 | Phase 1/Phase 2 | France |
| 119 | NCT03827603 (ClinicalTrials.gov) | February 21, 2017 | 24/1/2019 | Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia | Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia: ELaboration of Treatment Approach | AIHA - Warm Autoimmune Hemolytic Anemia | Drug: Ibrutinib | Eugene Nikitin | NULL | Active, not recruiting | 18 Years | N/A | All | 50 | Phase 2 | Russian Federation |
| 120 | EUCTR2016-002478-11-AT (EUCTR) | 19/07/2016 | 01/07/2016 | Very low doses of Rituximab for autoimmune diseases, for which rituximab is not approved for - a Pilot Trial | Very low doses of Rituximab for off-label treatment – a Pilot Trial - Low_Rituximab | Autoimmune-haemolytic AnemiaAntiphospholipid SyndromeImmune-mediated Thrombocytopenia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000154058 MedDRA version: 20.0;Classification code 10023095;Term: ITP;System Organ Class: 100000157088 MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Mabthera or biosimilar Rituximab Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB Other descriptive name: Rituximab | Medical University of Vienna, Department of Internal medicine I | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Austria | ||
| 121 | NCT02612558 (ClinicalTrials.gov) | July 2016 | 19/11/2015 | A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA) | A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm Antibody Autoimmune Hemolytic Anemia | Drug: Fostamatinib 150 mg bid | Rigel Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 26 | Phase 2 | United States;Canada |
| 122 | NCT02828670 (ClinicalTrials.gov) | June 7, 2016 | 23/6/2016 | Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA) | Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA) | Autoimmune Hemolytic Anemia | Biological: blood sample;Procedure: spleen sample | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 18 Years | N/A | All | 50 | France | |
| 123 | NCT02502903 (ClinicalTrials.gov) | July 13, 2015 | 7/7/2015 | Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders | Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement-mediated Disorders. A Single/Multiple Ascending Dose Phase 1 Study. | Bullous Pemphigoid (BP);Cold Agglutinin Disease (CAD);Warm Autoimmune Hemolytic Anemia (WAIHA);End-stage Renal Disease (ESRD) | Drug: BIV009;Other: Placebo | Bioverativ, a Sanofi company | Celerion Clinical Research GmbH;Assign Data Management and Biostatistics GmbH;ABF Pharmaceutical Services GmbH;Quest Diagnostics-Nichols Insitute;Covance Laboratories - Chantilly;PPD Laboratories - Virginia;Softworld Inc. - Cambridge, MA | Completed | 18 Years | N/A | All | 122 | Phase 1 | Austria |
| 124 | EUCTR2011-004835-30-FI (EUCTR) | 10/07/2013 | 17/06/2013 | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 | Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Department of Medicine, Haugesund Hospital | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Finland;Denmark;Norway | ||
| 125 | NCT02158195 (ClinicalTrials.gov) | July 3, 2013 | 5/3/2014 | Immunopathology of Autoimmune Hemolytic Anemia | Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study | Autoimmune Hemolytic Anemia | Biological: blood samples | Centre Hospitalier Universitaire Dijon | NULL | Completed | 16 Years | N/A | All | 27 | France | |
| 126 | EUCTR2012-003710-13-NL (EUCTR) | 21/03/2013 | 21/03/2013 | C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia – an open-labeled pilot trial | C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia – an open-labeled pilot trial - C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune h | AutoImmune Hemolytic Anemia MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: CINRYZE® (C1 esterase inhibitor [human]) | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Netherlands | ||
| 127 | EUCTR2011-004835-30-DK (EUCTR) | 17/01/2013 | 30/11/2012 | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 | Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Department of Medicine, Haugesund Hospital | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Finland;Denmark;Norway | ||
| 128 | NCT02689986 (ClinicalTrials.gov) | January 2013 | 16/2/2016 | Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease | The CAD5 Study::Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicenter Trial on the Safety and Efficacy of Bendamustine and Rituximab Combination Therapy | Cold Agglutinin Disease;Autoimmune Hemolytic Anemia | Drug: Bendamustine, Rituximab | Helse Fonna | NULL | Completed | 18 Years | N/A | All | 43 | Phase 2 | Denmark;Finland;Norway |
| 129 | NCT01696474 (ClinicalTrials.gov) | December 2012 | 27/9/2012 | Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease | Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease | Refractory Cold Agglutinin Disease | Drug: Bortezomib | Gruppo Italiano Malattie EMatologiche dell'Adulto | NULL | Completed | 18 Years | N/A | All | 21 | Phase 2 | Italy |
| 130 | EUCTR2011-004835-30-NO (EUCTR) | 23/10/2012 | 29/08/2012 | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. | Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 | Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Levact INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Department of Medicine, Haugesund Hospital | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Finland;Denmark;Norway | ||
| 131 | EUCTR2011-006329-42-IT (EUCTR) | 11/10/2012 | 30/10/2012 | Short treatment with a drug for patients affected by a type of a treatment-resistant anaemia, where the red cells are destroyed by some cold cells (autoantibodies). | Short course of Bortezomib in anemic patients with refractory cold agglutinin disease | Anaemia with refractory cold agglutinin disease MedDRA version: 14.1;Level: PT;Classification code 10009868;Term: Cold type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VELCADE*EV 1FL 3,5MG 1MG/ML | G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | Italy | ||
| 132 | NCT01579110 (ClinicalTrials.gov) | April 2012 | 13/4/2012 | Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia. | Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia. | Anemia;Anemia, Hemolytic;Anemia, Hemolytic, Autoimmune;Hemolysis;Hematologic Diseases;Autoimmune Diseases;Immune System Diseases;Pathologic Processes | Drug: levamisole;Drug: Prednisone | Institute of Hematology & Blood Diseases Hospital | NULL | Active, not recruiting | 18 Years | N/A | Both | 100 | Phase 2 | China |
| 133 | NCT01181154 (ClinicalTrials.gov) | March 3, 2011 | 12/8/2010 | Rituximab in Auto-Immune Hemolytic Anemia | Rituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled Trial | Warm Autoimmune Hemolytic Anemia | Drug: rituximab (Mabthera®);Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Hoffmann-La Roche | Completed | 18 Years | N/A | All | 32 | Phase 3 | France |
| 134 | NCT01303952 (ClinicalTrials.gov) | January 2011 | 24/2/2011 | Therapy of Chronic Cold Agglutinin Disease With Eculizumab | Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab | Cold Agglutinin Disease | Drug: Eculizumab | University Hospital, Essen | Alexion Pharmaceuticals | Completed | 18 Years | N/A | All | 13 | Phase 2 | Germany |
| 135 | EUCTR2009-016966-97-DE (EUCTR) | 08/06/2010 | 08/02/2010 | Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial | Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial | Cold agglutinin disease MedDRA version: 12.1;Level: LLT;Classification code 10009868;Term: Cold type haemolytic anaemia | Trade Name: Soliris (R) | Universitätsklinikum Essen | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 136 | NCT00960713 (ClinicalTrials.gov) | June 2009 | 16/7/2009 | The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders | The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders | Pemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;Cryoglobulinemia | Drug: Rituximab (MABTHERA® or RITUXAN®). | University Hospital, Toulouse | NULL | Completed | 18 Years | N/A | Both | 35 | N/A | France |
| 137 | EUCTR2007-001377-28-PT (EUCTR) | 09/01/2009 | 25/08/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 138 | NCT01345708 (ClinicalTrials.gov) | January 2009 | 28/4/2011 | A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia | A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Disease (Cold Type) (Warm Type) | Drug: prednisone, low dose rituximab | Fondazione Ospedale | University Hospital, Udine, Italy | Completed | 18 Years | N/A | Both | 23 | Phase 2 | Italy |
| 139 | EUCTR2008-006713-25-IT (EUCTR) | 23/09/2008 | 16/01/2009 | A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND | A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND | ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHE | INN or Proposed INN: Rituximab | OSPEDALE MAGGIORE DI MILANO (IRCCS) | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 140 | EUCTR2007-001377-28-DE (EUCTR) | 01/09/2008 | 15/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 141 | EUCTR2007-001377-28-NL (EUCTR) | 15/07/2008 | 29/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 142 | EUCTR2007-001377-28-AT (EUCTR) | 26/06/2008 | 27/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 143 | EUCTR2007-001377-28-FR (EUCTR) | 11/06/2008 | 29/02/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;France;Austria;Netherlands;Germany | ||
| 144 | NCT00392951 (ClinicalTrials.gov) | December 2006 | 24/10/2006 | Sirolimus for Autoimmune Disease of Blood Cells | Sirolimus for Patients With Chronic and/or Refractory Autoimmune Cytopenias: A Pilot Series | Autoimmune Pancytopenia;Autoimmune Lymphoproliferative Syndrome (ALPS);Evans Syndrome;Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune;Autoimmune Neutropenia;Lupus Erythematosus, Systemic;Inflammatory Bowel Disease;Rheumatoid Arthritis | Drug: sirolimus | Children's Hospital of Philadelphia | NULL | Completed | 1 Year | 30 Years | All | 30 | Phase 1/Phase 2 | United States |
| 145 | NCT00373594 (ClinicalTrials.gov) | June 2005 | 7/9/2006 | Therapy for Chronic Cold Agglutinin Disease | Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicentre Study on the Safety and Efficacy of Rituximab in Combination With Fludarabine. | Cold Agglutinin Disease | Drug: Rituximab;Drug: Fludarabine | University of Bergen | NULL | Completed | 18 Years | 90 Years | Both | 30 | Phase 2 | Norway;Russian Federation |
| 146 | NCT01134432 (ClinicalTrials.gov) | March 2005 | 28/5/2010 | Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia | Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial. | Anemia, Hemolytic, Autoimmune | Drug: prednisolone + mabthera;Drug: Prednisolone | Copenhagen University Hospital at Herlev | NULL | Completed | 18 Years | N/A | Both | 65 | Phase 3 | Denmark |