51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
| 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 | EUCTR2019-000906-31-DE (EUCTR) | 01/07/2020 | 31/10/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 2 | EUCTR2019-000906-31-GB (EUCTR) | 22/05/2020 | 29/10/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 3 | EUCTR2019-000906-31-BE (EUCTR) | 19/03/2020 | 09/12/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 4 | EUCTR2019-000906-31-IT (EUCTR) | 25/02/2020 | 22/01/2021 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis - NA | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: PRIVIGEN - 100 MG/ML - SOLUZIONE PER INFUSIONE USO ENDOVENOSO FLACONCINO(VETRO) 1 FLACONCINO DA 100 ML Product Name: Immunoglobulina normale umana per somministrazione endovenosa Product Code: [IgPro10] | CSL BEHRING GMBH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 5 | EUCTR2019-000906-31-PL (EUCTR) | 31/01/2020 | 06/12/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;Germany | ||
| 6 | NCT04138485 (ClinicalTrials.gov) | December 20, 2019 | 14/10/2019 | Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis | Biological: IgPro10;Biological: Placebo | CSL Behring | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom |
| 7 | EUCTR2019-000906-31-ES (EUCTR) | 16/12/2019 | 20/12/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 8 | EUCTR2019-000906-31-FR (EUCTR) | 03/12/2019 | 08/11/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 9 | EUCTR2018-003149-41-DE (EUCTR) | 16/07/2019 | 20/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;United Kingdom;Italy | ||
| 10 | EUCTR2018-003149-41-FR (EUCTR) | 24/05/2019 | 27/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Poland;Australia;Germany;Italy;United Kingdom | ||
| 11 | EUCTR2018-003149-41-IT (EUCTR) | 23/05/2019 | 22/01/2021 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - NA | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemicsclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Immunoglobulina Normale Umana per somministrazione sottocutanea Product Code: [IgPro20] INN or Proposed INN: IMMUNOGLOBULINA UMANA NORMALE Trade Name: Privigen Product Name: immunoglobulina Normale Umana per somministrazione endovenosa Product Code: [IgPro10] INN or Proposed INN: immunoglobulina normale umana | CSL BEHRING GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;United Kingdom;Italy | ||
| 12 | EUCTR2018-003149-41-GB (EUCTR) | 15/05/2019 | 30/07/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;Italy;United Kingdom | ||
| 13 | NCT03630211 (ClinicalTrials.gov) | July 31, 2018 | 7/8/2018 | Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc) | Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary Hypertension | Drug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation;Drug: Anti Thymocyte Globulin | Paul Szabolcs | NULL | Recruiting | 8 Years | 60 Years | All | 8 | Phase 2 | United States |
| 14 | NCT01785056 (ClinicalTrials.gov) | April 2013 | 28/1/2013 | IVIG Treatment in Systemic Sclerosis | A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis | Systemic Sclerosis;Diffuse Scleroderma | Biological: Privigen | Georgetown University | CSL Behring | Unknown status | 18 Years | N/A | All | 14 | N/A | United States |
| 15 | NCT00348296 (ClinicalTrials.gov) | July 2006 | 3/7/2006 | Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis | Scleroderma, Systemic | Drug: High-dose intravenous immunoglobulin (Venoglobulin-IH) | Benesis Corporation | NULL | Completed | 16 Years | N/A | Both | 60 | Phase 3 | Japan |