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 | NCT02551042 (ClinicalTrials.gov) | September 2015 | 17/12/2014 | CSL Behring Sclero XIII | A Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chloride | University College, London | CSL Behring | Recruiting | 18 Years | N/A | Both | 26 | Phase 2 | United Kingdom |
2 | EUCTR2014-001101-40-GB (EUCTR) | 24/02/2015 | 14/01/2015 | Investigation of safety and therapeutic effect of Fibrogammin® in Scleroderma | Sclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic sclerosis - Sclero XIII | Systemic Sclerosis MedDRA version: 17.1;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859 MedDRA version: 17.1;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Fibrogammin® 1250 Product Name: Fibrogammin® 1250 INN or Proposed INN: blood coagulation factor XIII | University College London (UCL) | NULL | Not Recruiting | 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 | United Kingdom |