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 | 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 | ||
| 2 | EUCTR2010-019977-14-IT (EUCTR) | 04/11/2010 | 27/12/2010 | Efficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - ND | Efficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - ND | Patients affected by Systemic Sclerosis with Raynaud’s Phenomenon MedDRA version: 9.1;Level: LLT;Classification code 10042953 | Trade Name: PLETAL INN or Proposed INN: CILOSTAZOL | AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 3 | EUCTR2008-001265-28-IT (EUCTR) | 02/03/2010 | 07/12/2009 | Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - ND | Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - ND | skin fibrosis of systemic sclerosis patients MedDRA version: 12.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144. Cytokines Inhibitors Product Code: P144 INN or Proposed INN: P144 Cytokines Inhibitors | ISDIN S.A. | NULL | Not Recruiting | Female: yes Male: yes | 98 | Hungary;United Kingdom;Germany;Spain;Italy | |||
| 4 | EUCTR2007-002015-38-IT (EUCTR) | 05/06/2009 | 19/06/2009 | Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND | Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND | Skin Fibrosis in patients with systemic sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 | ISDIN S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | Hungary;Germany;United Kingdom;Spain;Italy | ||
| 5 | EUCTR2007-004669-17-IT (EUCTR) | 17/12/2008 | 16/06/2008 | A multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis - ND | A multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis - ND | sistemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10018124;Term: Generalized scleroderma | Trade Name: GLIVEC INN or Proposed INN: IMATINIB MESILATO | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 27 | United Kingdom;Italy | |||
| 6 | EUCTR2007-003621-24-IT (EUCTR) | 15/07/2008 | 17/11/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil | MONDOGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 7 | EUCTR2007-006035-32-IT (EUCTR) | 15/11/2007 | 15/01/2008 | Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - ND | Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - ND | Systemic Sclerosis and Hypercholesterolemia. MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: SINVACOR*28CPR RIV 20MG INN or Proposed INN: Simvastatin | AZIENDA OSPEDALIERA PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 8 | EUCTR2007-001508-19-IT (EUCTR) | 06/09/2007 | 29/07/2008 | TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND | TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND | GVH CRONICA ESTESA MedDRA version: 9.1;Level: LLT;Classification code 10018651;Term: Graft versus host disease | Trade Name: GLIVEC INN or Proposed INN: Imatinib | AZIENDA OSPEDALIERA S. CARLO | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 9 | EUCTR2006-005230-20-IT (EUCTR) | 14/07/2006 | 12/07/2007 | EX VIVO EFFECT OF AMINAFTONE (CAPILLAREMA) ON THE ENDOTELIAL FUNCTION IN SYSTEMIC SCLEROSIS.Effetto ex vivo dell’aminaftone (Capillarema) sulla funzione endoteliale nella Sclerosi Sistemica - ND | EX VIVO EFFECT OF AMINAFTONE (CAPILLAREMA) ON THE ENDOTELIAL FUNCTION IN SYSTEMIC SCLEROSIS.Effetto ex vivo dell’aminaftone (Capillarema) sulla funzione endoteliale nella Sclerosi Sistemica - ND | Variazione della gravita' del fenomeno di Raynaud misurata mediante diario dei sintomi e scala analogica visiva VAS ? Visual Analogic Scale (6). Variazione dello stato globale di malattia valutata mediante HAQ ? Health Assessment Questionnaire (7). MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: CAPILLAREMA | OSPEDALE MAGGIORE DI MILANO (IRCCS) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy |