60. 再生不良性貧血 Aplastic anemia Clinical trials / Disease details
臨床試験数 : 245 / 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
| 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 | ChiCTR2200060098 | 2022-05-05 | 2022-05-18 | A retrospective study to assess the efficacy and safety of eltrombopag in combination with immunosuppressants in treatment-naive patients with SAA | A retrospective study to assess the efficacy and safety of eltrombopag in combination with immunosuppressants in treatment-naive patients with SAA | Aplastic anemia | Experimental group:Eltrombopag combined with immunosuppressive therapy (IST);Control group:IST; | The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine | NULL | Pending | 16 | 80 | Both | Experimental group:132;Control group:66; | Phase 4 | China |
| 2 | ChiCTR2100054957 | 2021-12-24 | 2021-12-29 | A prospective controlled study evaluating the efficacy and safety of eltrombopag combined with immunosuppressive agents in treatment-na?ve patients with SAA | A prospective controlled study evaluating the efficacy and safety of eltrombopag combined with immunosuppressive agents in treatment-na?ve patients with SAA | Aplastic anemia (AA) | Group 1:Eltrombopag + Immunosuppressive Therapy (IST);Group 2: Immunosuppressive Therapy (IST); | The First Affiliated Hospital of Zhejiang Medical University | NULL | Recruiting | 16 | 80 | Both | Group 1:132;Group 2:66; | Phase 4 | China |
| 3 | NCT05049668 (ClinicalTrials.gov) | October 2021 | 13/9/2021 | RACE 2: a Long Term Follow-up of Patients Participating in the RACE Trial | Long-term Follow-up of Patients Participating in RACE: the Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients | Severe Aplastic Anemia | Drug: ATGAM plus CsA with or without Eltrombopag | European Society for Blood and Marrow Transplantation | NULL | Enrolling by invitation | N/A | N/A | All | 197 | France | |
| 4 | ChiCTR2100043229 | 2021-02-22 | 2021-02-09 | A Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic Anemia | A Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic Anemia | Aplastic anemia | Durgs Group:Elrombopag combined with Cyclosporine; | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | NULL | Recruiting | 18 | 85 | Both | Durgs Group:61; | Phase 2 | China |
| 5 | NCT04328727 (ClinicalTrials.gov) | November 4, 2020 | 9/3/2020 | Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia | A Non-randomized, Open Label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin (r-ATG) and Cyclosporine A (CsA) in East-Asian Patients With Treatment Naive Severe Aplastic Anemia (REACTS) | Severe Aplastic Anemia (SAA) | Drug: eltrombopag;Drug: rabbit anti-thymocyte globulin (r-ATG);Drug: cyclosporine A (CsA) | Novartis Pharmaceuticals | NULL | Active, not recruiting | 6 Years | N/A | All | 36 | Phase 2 | China;Japan;Korea, Republic of;Taiwan |
| 6 | NCT04403321 (ClinicalTrials.gov) | July 1, 2020 | 21/5/2020 | Efficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia Patients | Efficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia Patients | Aplastic Anemia;Drug Effect | Drug: Tacrolimus;Drug: Placebo (for Tacrolimus) | Peking Union Medical College Hospital | NULL | Completed | 14 Years | 85 Years | All | 114 | Phase 2 | China |
| 7 | NCT04304820 (ClinicalTrials.gov) | May 7, 2020 | 10/3/2020 | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) | Severe Aplastic Anemia | Drug: Eltrombopag;Drug: Cyclosporine;Drug: Horse-Anti-thymocyte-Globulin | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 3 Years | N/A | All | 39 | Phase 2 | United States |
| 8 | NCT03988608 (ClinicalTrials.gov) | December 9, 2019 | 13/6/2019 | Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects. | A Non-randomized, Open-label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Subjects With Refractory or Relapsed Severe Aplastic Anemia | Aplastic Anemia | Drug: Eltrombopag 25 mg | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 2 | China |
| 9 | JPRN-jRCTs071190032 | 26/11/2019 | 21/10/2019 | W-JHS AA02 | Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02 | aplastic anemia | 1. The administration of rATG; 2.5 mg/kg, iv. daily, day 1 - day 5 + CsA; 5 mg/kg, po. bid (before breakfast and before dinner) +adrenalcorticosteroid (the dose is mentioned after) is started. CsA used is Neoral or generic drug emulsified in the same way with Neoral. A blood level of CsA is measured and the dose which CsA blood level 2 hours after oral administration (C2) reachs 600 - 900 ng/mL is adjusted. The investigator shall reduce the dose of CsA by 25% on this occasion when blood trough level (C0) just before the administration is beyond 250 ng/mL because renal function disorder may occur (2). When serum creatinine level also becomes higher than 150% of baselines, the 25% dose reduction of CsA shall be performed. If C2 did not reach to 600 ng/mL, then dose of CsA is appropriately increased. 2. EPAG; 75 mg, po. daily (before sleep, requires to pass more than at least 2 hours after dinner) is started from day 6. 3. The dose of steroid is as follows: Day 1 - day 5: methylprednisolone 2 mg/kg/day Day 6: Methylprednisolone 1 mg/kg/day Day 8, 10, 12, 14, 16, 18, 20: prednisolone 0.5 mg/kg/day Discontinuation after day 21 4. The administration of CsA and EPAG is continued for 26 weeks. When it passed 26 weeks, further treatment mentioned above is entrusted to the investigator in each medical institution after 27 weeks if patients reached Camitta criteria CR or PR. However, the administration is continued for 52 weeks even if the dose of CsA is reduced. The treatment after 53 weeks is not specified. If patients did not reach CR or PR at 26 weeks, treatment after 27 weeks is entrusted to the investigator in each medical institution (it is not specified in this study). | Ishiyama Ken | NULL | Recruiting | >= 18age old | < 80age old | Both | 60 | Phase 2 | Japan |
| 10 | EUCTR2016-002814-29-IT (EUCTR) | 14/06/2019 | 24/05/2021 | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: SANDIMMUN NEORAL - 10 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral ] INN or Proposed INN: 00070500 Other descriptive name: CICLOSPORINA Trade Name: SANDIMMUN NEORAL - 25 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Other descriptive name: CICLOSPORINA Trade Name: SANDIMMUN NEORAL - 50 MG CAPSULE MOLLI 50 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Trade Name: SANDIMMUN NEORAL - 100 MG CAPSULE MOLLI 30 CAPSULE Product Name: Sandimmun Neoral Product Code: [Sandimmun Neoral] INN or Proposed INN: 00070500 Trade Name: REVOLADE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU) 28 COMPRESSE Product Name: Eltrombopag Product Code: [ETB115] INN or Proposed INN: 00319301 Other descriptive name: Eltrombopag Trade Name: REVOLADE - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Hong Kong;Mexico;Spain;Thailand;Brazil;Korea, Democratic People's Republic of;Turkey;Netherlands;Italy;India | ||
| 11 | EUCTR2015-003166-91-GB (EUCTR) | 22/05/2019 | 05/07/2017 | A phase II dose escalation study: use of eltrombopag in pediatric patientswith severe aplastic anemia or recurrent aplastic anemia | A phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. | Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA) MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom | ||
| 12 | EUCTR2015-003166-91-NL (EUCTR) | 14/11/2018 | 08/08/2017 | A phase II dose escalation study: use of eltrombopag in pediatric patients with severe aplastic anemia or recurrent aplastic anemia | A phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. | Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA) MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Portugal;United States;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom | ||
| 13 | NCT03243656 (ClinicalTrials.gov) | December 20, 2017 | 2/8/2017 | Eltrombopag & Cyclosporine in Children With Sever Aplastic Anemia | Randomized Clinical Trial of the Use of & Cyclosporine in Children With Sever Idiopathic Aplastic Anemia | Eltrombopag | Drug: Eltrombopag | Assiut University | NULL | Completed | 1 Year | 18 Years | All | 20 | Phase 4 | Egypt |
| 14 | EUCTR2015-003166-91-PT (EUCTR) | 15/12/2017 | 13/07/2017 | A phase II dose-escalation study characterizing the PK of eltrombopag in pediatric patients with previously untreated or relapsed severe aplastic anemia or recurrent aplastic anemia. | A phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia. | Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA) MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom | ||
| 15 | NCT03025698 (ClinicalTrials.gov) | September 30, 2017 | 12/1/2017 | A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia | A Phase II, Open-label, Non-controlled, Intra-patient Dose-escalation Study to Characterize the Pharmacokinetics After Oral Administration of Eltrombopag in Pediatric Patients With Refractory, Relapsed or Treatment Naive Severe Aplastic Anemia or Recurrent Aplastic Anemia | Aplastic Anemia | Drug: Eltrombopag;Drug: hATG;Drug: CsA | Novartis Pharmaceuticals | NULL | Active, not recruiting | 1 Year | 18 Years | All | 51 | Phase 2 | United States;Hong Kong;Portugal;Russian Federation;Thailand;United Kingdom;Netherlands |
| 16 | EUCTR2016-002814-29-HU (EUCTR) | 07/09/2017 | 05/07/2017 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months. | SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hong Kong;Hungary;Mexico;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India | ||
| 17 | EUCTR2016-002814-29-NL (EUCTR) | 21/07/2017 | 29/03/2017 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months. | SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR | First-line severe aplastic anaemia MedDRA version: 20.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Hong Kong;Mexico;Thailand;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India | ||
| 18 | EUCTR2016-002814-29-ES (EUCTR) | 21/03/2017 | 16/12/2016 | SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months. | SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOAR | First-line severe aplastic anaemia MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG Trade Name: REVOLADE Product Name: Eltrombopag Product Code: ETB115 INN or Proposed INN: ELTROMBOPAG | Novartis Farmacéutica, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Qatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of | ||
| 19 | NCT03413306 (ClinicalTrials.gov) | December 10, 2016 | 22/12/2017 | Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA | A Phase II Multicenter Randomized Study of Eltrombopag Combined With Cyclosporine and hATG Versus hATG and CsA as First Line Treatment in Pediatric Patients With Severe Acquired Aplastic Anemia | Acquired Aplastic Anemia | Drug: Eltrombopag;Drug: IST (ATG + CsA) | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | NULL | Recruiting | 2 Years | 18 Years | All | 100 | Phase 3 | Russian Federation |
| 20 | EUCTR2014-000363-40-NL (EUCTR) | 07/01/2016 | 01/09/2015 | A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function. | A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE | Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia. MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: REVOLADE INN or Proposed INN: ELTROMBOPAG | European Society for Blood and Marrow Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Spain;Netherlands | ||
| 21 | EUCTR2014-000363-40-ES (EUCTR) | 26/10/2015 | 07/09/2015 | A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function. | A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE | Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia. MedDRA version: 18.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade INN or Proposed INN: ELTROMBOPAG | European Society for Blood and Marrow Transplantation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Spain | |||
| 22 | NCT02099747 (ClinicalTrials.gov) | July 2015 | 6/3/2014 | hATG+CsA vs hATG+CsA+Eltrombopag for SAA | A Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients. | Severe Aplastic Anemia | Drug: hATG;Drug: CsA;Drug: Eltrombopag | European Group for Blood and Marrow Transplantation | Novartis;Pfizer | Active, not recruiting | 15 Years | N/A | All | 202 | Phase 3 | France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany |
| 23 | NCT02404025 (ClinicalTrials.gov) | May 12, 2015 | 26/2/2015 | Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects | A Non-randomized, Phase II Study of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A (ATG/CsA) in Subjects With Moderate or More Severe Aplastic Anemia Who Have Not Received Prior ATG/Anti-lymphocyte Globulin (ALG)-Based Immunosuppressive Therapy | Aplastic Anemia | Drug: Eltrombopag;Drug: Rabbit ATG;Drug: CsA | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 2 | Japan |
| 24 | EUCTR2014-000174-19-DE (EUCTR) | 27/01/2015 | 01/09/2014 | Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A | Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopagwith Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A - EMAA | Moderate Aplastic Anemia (MAA);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade 75 mg Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag Other descriptive name: ELTROMBOPAG OLAMINE | Universitätsklinikum Ulm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2;Phase 3 | France;Germany;Switzerland | ||
| 25 | NCT02773225 (ClinicalTrials.gov) | January 27, 2015 | 29/2/2016 | Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA) | Efficacy and Safety of Thrombopoetin-Receptor Agonist Eltrombopag in in Combination With Ciclosporin A in Moderate Aplastic Anemia (EMAA): Prospective Randomized Multicenter Study | Anemia, Aplastic | Drug: Eltrombopag;Drug: Placebo (for Eltrombopag) | B. Höchsmann | NULL | Recruiting | 18 Years | N/A | All | 116 | Phase 2/Phase 3 | Germany |
| 26 | NCT02148133 (ClinicalTrials.gov) | July 23, 2014 | 22/5/2014 | A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia | A Non-randomized, Open-label, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia | Cytopaenia | Drug: Eltrombopag 12.5 mg;Drug: Eltrombopag 25 mg | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 79 Years | All | 21 | Phase 2 | Japan |
| 27 | NCT01891994 (ClinicalTrials.gov) | June 28, 2013 | 28/6/2013 | Extended Dosing With Eltrombopag for Severe Aplastic Anemia | Extended Dosing With Eltrombopag in Refractory Severe Aplastic Anemia | Severe Aplastic Anemia (SAA) | Drug: Eltrombopag | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Active, not recruiting | 2 Years | 100 Years | All | 40 | Phase 2 | United States |
| 28 | NCT01703169 (ClinicalTrials.gov) | November 2012 | 27/9/2012 | Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia | Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia | Severe Aplastic Anemia;Very Severe Aplastic Anemia;Moderate Aplastic Anemia | Drug: Eltrombopag | University of Utah | Novartis | Completed | 18 Years | N/A | All | 13 | Phase 2 | United States |
| 29 | NCT01623167 (ClinicalTrials.gov) | July 2, 2012 | 14/6/2012 | Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia | Eltrombopag Added to Standard Immunosuppression in Treatment-Naive Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: Cohort 1: hATG, CsA, EPAG Day 14 to Month 6;Drug: Cohort 2: hATG, CsA, EPAG Day 14 to Month 3;Drug: Cohort 3: hATG, CsA (dose reduced), EPAG day 1 to month 6;Drug: Extension Cohort | National Heart, Lung, and Blood Institute (NHLBI) | Novartis | Recruiting | 2 Years | 95 Years | All | 207 | Phase 1/Phase 2 | United States |
| 30 | NCT01328587 (ClinicalTrials.gov) | April 1, 2011 | 1/4/2011 | Eltrombopag for Moderate Aplastic Anemia | A Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Moderate Aplastic Anemia Patients | Moderate Aplastic Anemia;Unilineage Bone Marrow Failure Disorders | Drug: Eltrombopag | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Active, not recruiting | 2 Years | 100 Years | All | 34 | Phase 2 | United States |
| 31 | NCT00922883 (ClinicalTrials.gov) | May 29, 2009 | 16/6/2009 | A Pilot Study of the Thrombopoietin-Receptor Agonist Eltrombopag in Refractory Aplastic Anemia Patients | A Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Aplastic Anemia Patients With Immunosuppressive-Therapy Refractory Thrombocytopenia | Anemia, Aplastic;Anemia, Hypoplastic;Thrombocytopenia | Drug: Eltrombopag | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 12 Years | N/A | All | 43 | Phase 2 | United States |