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

  
8 trials found
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1EUCTR2014-002796-28-NL
(EUCTR)
12/04/201623/04/2015Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes?The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers. - CEASE STIFFNESS Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Tracleer
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
University Medical Center Groningen (UMCG)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
2EUCTR2011-005303-32-NL
(EUCTR)
05/03/201226/01/2012The effect of bosentan in scleroderma patients with a specific nailfold pattern (HOME II)Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II) - HOME II Digital Ulcera in Systemic Sclerodermia patients
MedDRA version: 14.1;Level: PT;Classification code 10053400;Term: Endothelin increased;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Tracleer
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals Nederland bvNULLNot RecruitingFemale: yes
Male: yes
Netherlands
3EUCTR2010-021452-26-FR
(EUCTR)
20/09/201009/07/2010Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBOCrise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBO Les patients inclus dans l'étude seront des patients atteints de sclérodermie systémique (définie selon les critères de la classification de l'ACR et/ou de Leroy et Medsger) et présentant une crise rénale sclérodermique aigue définie par une HTA sévère d'emblée et/ou d'aggravation progressive >150/85mmHg obtenue à deux reprises minimum en 24H, sans autre explication que la ScS et/ou une insuffisance rénale rapidement progressive, sans autre explication que la ScS.
MedDRA version: 8.1;Level: PT;Classification code 10062553;Term: scleroderma renal crisis
Trade Name: Tracleer
Product Name: Tracleer
INN or Proposed INN: bosentan
Trade Name: Tracleer
Product Name: Tracleer
INN or Proposed INN: Bosentan
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
Phase 3France
4NCT00318175
(ClinicalTrials.gov)
June 200624/4/2006Effect of Bosentan on Skin Fibrosis in Patients With Systemic SclerosisStudy to Assess the Effect of Bosentan on the Treatment of Skin Fibrosis in Patients With Systemic Sclerosis (BTSF)Systemic Scleroderma;Skin Fibrosis;Hand FunctionalityDrug: Bosentan (Tracleer)Heinrich-Heine University, DuesseldorfNULLCompleted18 YearsN/ABoth10Phase 2Germany
5EUCTR2005-000701-61-GB
(EUCTR)
29/11/200527/10/2005An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 Scleroderma renal crisisTrade Name: Tracleer
Product Name: Bosentan
Product Code: N/A
University College LondonNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):United Kingdom
6EUCTR2004-000632-82-IT
(EUCTR)
06/04/200515/03/2007Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcersLong term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers Healing and prevention of ischemic digital ulcers in patients with systemic sclerosis
Level: PTClassification code 10059084
Trade Name: TRACLEER*56CPR RIV 125MG
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
180Italy
7EUCTR2004-000632-82-GB
(EUCTR)
16/09/200411/02/2005Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extensionLong term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the diseaseTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Italy;United Kingdom
8EUCTR2004-000631-28-IT
(EUCTR)
14/09/200417/09/2004Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2.Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. Interstitial lung disease associated with systemic sclerosisTrade Name: TRACLEER*125MG 56CPR RIV.
Product Name: NA
Product Code: NA
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
Italy