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 | NCT04040322 (ClinicalTrials.gov) | October 14, 2019 | 30/7/2019 | Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3) | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study) | Raynaud's Phenomenon Secondary to Systemic Sclerosis | Drug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous use | Eicos Sciences, Inc. | NULL | Completed | 18 Years | N/A | All | 198 | Phase 3 | United States |
| 2 | NCT03867097 (ClinicalTrials.gov) | March 4, 2019 | 6/3/2019 | Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2) | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis | Raynaud Phenomenon Secondary to Systemic Sclerosis | Drug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous use | Eicos Sciences, Inc. | NULL | Completed | 18 Years | N/A | All | 41 | Phase 2 | United States |
| 3 | EUCTR2016-002984-32-IT (EUCTR) | 16/02/2017 | 05/02/2018 | ND | Treatment of the Reynaud's Disease associated with ischemic ulcers in patients affected by sistemic sclerosis - ND | SISTEMIC SCLEROSIS MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA Product Name: ENDOPROST INN or Proposed INN: ILOPROST TROMETAMOL Other descriptive name: ILOPROST SALE DI TROMETAMOLO Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA Product Name: ENDOPROST Product Code: ND INN or Proposed INN: ILOPROST TROMETAMOL Other descriptive name: ILOPROST SALE DI TROMETAMOLO | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 238 | Phase 4 | Italy | ||
| 4 | EUCTR2013-004596-12-IT (EUCTR) | 22/01/2014 | 13/12/2013 | Infusion at home ,using a pump device, of a drug that dilates peripheral blood vessels to treat patients affected by a disease named Systemic sclerosis, with manifestations caused by a reduced blood flow in hands and feet. | HOME INFUSION THERAPY WITH ILOPROST USING A PORTABLE SYRINGE PUMP FOR THE TREATMENT OF PERIPHERAL ULCERS AND RAYNAUD'S PHENOMENON IN SYSTEMIC SCLEROSIS. - iloporta | Raynaud's phenomenon and acral ulcers in systemic sclerosis;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Endoprost Product Name: Endoprost | Azienda ospedaliera universitaria Ospedali Riuniti | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 5 | NCT00428883 (ClinicalTrials.gov) | January 2007 | 29/1/2007 | High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis | Rare Disease With Microvascular Involvement: High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis | Scleroderma, Diffuse | Drug: N-acetylcysteine (NAC) | Università Politecnica delle Marche | NULL | Recruiting | 18 Years | 80 Years | Both | 45 | Phase 2/Phase 3 | Italy |
| 6 | EUCTR2006-003957-25-IT (EUCTR) | 13/10/2006 | 09/07/2007 | Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidlyprogressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc | Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidlyprogressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc | Systemic Scleroderma MedDRA version: 9.1;Level: LLT;Classification code 10055953;Term: Scleroedema | Trade Name: HIDONAC*EV 1FL 5G 25ML INN or Proposed INN: Acetylcysteine Trade Name: ENDOPROST 50*INFUS 1F 0,050MG/ INN or Proposed INN: Iloprost | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 7 | EUCTR2006-000905-41-AT (EUCTR) | 07/06/2006 | 08/05/2006 | Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud | Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud | Raynaud syndrome with / without systemic sclerosis | Trade Name: Ilomedin Product Name: Ilomedin Product Code: 1-22460 | ao. Univ. Prof. Dr. Elisabeth Aberer | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Austria | |||
| 8 | EUCTR2004-002712-28-IT (EUCTR) | 28/02/2005 | 15/02/2006 | Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study. | Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study. | Disease progression in scleroderma. MedDRA version: 6.1;Level: HLT;Classification code 10039711 | Trade Name: ENDOPROST 0,05MG/0,5ML 1F INN or Proposed INN: iloprost trometamol | ITALFARMACO | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | Italy | ||
| 9 | NCT00622687 (ClinicalTrials.gov) | September 1997 | 14/2/2008 | Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis | Comparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment Course | Systemic Sclerosis | Drug: iloprost;Drug: iloprost low dose;Drug: iloprost therapy up to 2 ng/kg x min | Charite University, Berlin, Germany | Schering-Plough | Terminated | 18 Years | 80 Years | Both | 50 | Phase 2 | Germany |
| 10 | NCT00004786 (ClinicalTrials.gov) | December 1995 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis | Systemic Sclerosis;Raynaud Disease | Drug: iloprost | National Center for Research Resources (NCRR) | University of Pittsburgh | Completed | 18 Years | N/A | Both | 200 | Phase 3 | NULL |