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 | EUCTR2019-002444-24-GB (EUCTR) | 18/02/2020 | 18/12/2019 | Clinical trial of a single dose of treprostinil injected as a depot under the skin to investigate the effect on the digital blood flow and safety in patients with Raynaud’s Phenomenon due to Systemic Sclerosis | An Exploratory Trial Assessing Vascular Digital Perfusion, Pharmacokinetics, Safety and Tolerability Following a Single Dose of CAM2043 (Treprostinil Subcutaneous Depot) in Patients with Raynaud’s Phenomenon Secondary to Systemic Sclerosis | Raynaud’s phenomenon secondary to systemic sclerosis MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CAM2043 Product Code: CAM2043 INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM | Camurus AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United Kingdom | ||
| 2 | NCT03120533 (ClinicalTrials.gov) | June 20, 2017 | 23/3/2017 | Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study | Therapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study | Scleroderma, Systemic | Drug: Iontophoresis of treprostinil;Drug: Iontophoresis of placebo | University Hospital, Grenoble | Linksium;University Grenoble Alps | Completed | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | France |
| 3 | NCT02663895 (ClinicalTrials.gov) | October 2016 | 19/1/2016 | Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis | A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis | Systemic Sclerosis;Calcinosis | Drug: Oral treprostinil | Stanford University | United Therapeutics | Completed | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 4 | NCT01554540 (ClinicalTrials.gov) | February 2012 | 7/2/2012 | Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study | Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers | Scleroderma, Systemic | Drug: Cutaneous iontophoresis of treprostinil | University Hospital, Grenoble | NULL | Active, not recruiting | 18 Years | N/A | Both | 40 | Phase 1/Phase 2 | France |
| 5 | NCT00848107 (ClinicalTrials.gov) | September 2009 | 16/2/2009 | Open-Label Study of Oral Treprostinil in Digital Ulcers | Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study | Systemic Sclerosis | Drug: treprostinil diethanolamine | United Therapeutics | NULL | Terminated | 18 Years | N/A | All | 115 | Phase 2 | United States;Canada;United Kingdom |
| 6 | NCT00775463 (ClinicalTrials.gov) | May 2009 | 17/10/2008 | Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine | DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study | Systemic Sclerosis;Scleroderma | Drug: treprostinil diethanolamine;Drug: placebo | United Therapeutics | NULL | Completed | 18 Years | N/A | All | 148 | Phase 2 | United States;Canada;United Kingdom |
| 7 | EUCTR2008-006978-15-GB (EUCTR) | 05/03/2009 | 22/05/2009 | DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT | DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT | Systemic Sclerosis, scleroderma digital ulcers MedDRA version: 14.0;Level: PT;Classification code 10039710;Term: Scleroderma;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C-SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15 SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | United Kingdom;Canada;United States | |||
| 8 | EUCTR2008-005018-39-GB (EUCTR) | 05/03/2009 | 22/05/2009 | DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1 | DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1 | Systemic Sclerosis, scleroderma digital ulcers MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C-SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | United Kingdom | |||
| 9 | NCT00848939 (ClinicalTrials.gov) | December 2008 | 19/2/2009 | Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis | An Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: treprostinil diethanolamine | United Therapeutics | NULL | Completed | 18 Years | N/A | Both | 28 | Phase 1 | United States |