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 | EUCTR2008-001265-28-GB (EUCTR) | 14/11/2008 | 19/08/2008 | 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 - OLE | 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 - OLE | Skin fibrosis in patients with systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144. Cytokines Inhibitors INN or Proposed INN: P144 Other descriptive name: DIGNA P144 cream | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| 2 | EUCTR2008-001265-28-DE (EUCTR) | 13/10/2008 | 19/05/2008 | OFFENE (UNVERBLINDETE) VERLÄNGERUNGSTUDIE FÜR PATIENTEN AUS DER ISD002-P144-07 STUDIE MIT TOPISCH AUFGETRAGENEM P144 AUF HAUTFIBROSEN BEI PATIENTEN MIT SYSTEMISCHER SKLEROSEOpen 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” - OLE | OFFENE (UNVERBLINDETE) VERLÄNGERUNGSTUDIE FÜR PATIENTEN AUS DER ISD002-P144-07 STUDIE MIT TOPISCH AUFGETRAGENEM P144 AUF HAUTFIBROSEN BEI PATIENTEN MIT SYSTEMISCHER SKLEROSEOpen 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” - OLE | Skin fibrosis in patients with systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Cytokine Inhibitor INN or Proposed INN: P144 Other descriptive name: DIGNA P144 cream | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Hungary;Spain;Germany;Italy;United Kingdom | |||
| 3 | EUCTR2008-001265-28-HU (EUCTR) | 18/09/2008 | 05/08/2008 | 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.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLE | 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.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLE | Skin fibrosis in patients with systemic sclerosis.Szisztémás szklerózisban szenvedo betegek. MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Cytokines Inhibitors INN or Proposed INN: P144 Other descriptive name: DIGNA P144 cream | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Hungary;United Kingdom;Germany;Spain;Italy | |||
| 4 | NCT00781053 (ClinicalTrials.gov) | July 2008 | 24/10/2008 | Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study | Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study With P144 Topical Adminsitration for Skin Fibrosis in Patients With Systemic Sclerosis | Skin Fibrosis | Drug: P144 cream | ISDIN | Digna Biotech S.L. | Completed | 18 Years | 65 Years | Both | 38 | Phase 2 | Germany;Hungary;Italy;Poland;Spain;United Kingdom |
| 5 | EUCTR2008-001265-28-ES (EUCTR) | 17/06/2008 | 08/04/2008 | Estudio abierto de extensión con P144 para la ampliación del tratamiento tópico de la fibrosis cutánea de pacientes con esclerosis sistémica previamente tratados en el ensayo ISD002-P144-07 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” - OLE | Estudio abierto de extensión con P144 para la ampliación del tratamiento tópico de la fibrosis cutánea de pacientes con esclerosis sistémica previamente tratados en el ensayo ISD002-P144-07 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” - OLE | Fibrosis cutánea de pacientes con esclerosis sistémicaSkin fibrosis in patients with systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144. Cytokines Inhibitors INN or Proposed INN: P144 Other descriptive name: DIGNA P144 cream | ISDIN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Hungary;United Kingdom;Germany;Spain;Italy | |||
| 6 | EUCTR2007-002015-38-DE (EUCTR) | 20/12/2007 | 03/08/2007 | 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. | 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. | SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Other descriptive name: DIGNA P144 CREAM | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Hungary;Spain;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2007-002015-38-GB (EUCTR) | 19/12/2007 | 31/07/2007 | 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. | 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. | SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 DIGNA CREAM Product Code: P144 Other descriptive name: DIGNA P144 CREAM | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Spain;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2007-002015-38-HU (EUCTR) | 04/09/2007 | 09/07/2007 | 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.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében. | 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.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében. | SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Other descriptive name: DIGNA P144 CREAM | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Hungary;Germany;United Kingdom;Spain;Italy | ||
| 9 | EUCTR2007-002015-38-ES (EUCTR) | 23/08/2007 | 02/07/2007 | ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE 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 | ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE 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 | FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICASKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Other descriptive name: DIGNA P144 CREAM | ISDIN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | Hungary;Germany;United Kingdom;Spain;Italy |