51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
| 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 | NCT04137224 (ClinicalTrials.gov) | September 19, 2019 | 21/10/2019 | 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) | Diffuse Cutaneous Systemic Sclerosis | Biological: IgPro20;Biological: IgPro10 | CSL Behring | NULL | Active, not recruiting | 18 Years | N/A | All | 27 | Phase 2 | Australia;Germany;Italy;Poland;United Kingdom;France |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |