Status:
COMPLETED
Effect of Bosentan in Scleroderma Renal Crisis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Actelion
Conditions:
Scleroderma Renal Crisis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that invo...
Detailed Description
Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that invo...
Eligibility Criteria
Inclusion
- Men or women ≥ 18 years
- Patients had to fulfil ACR and/or LEROY et MEDSGER criteria for systemic sclerosis
- Patients had to fulfil criteria for renal systemic sclerosis
- Written informed consent obtained
Exclusion
- Scleroderma renal crisis occuring before the age of eighteen
- Patients who are receiving bosentan within one month of inclusion for pulmonary arterial hypertension or digital ulcers prevention
- Other treatment by selective or nonselective antagonist endothelin receptor
- Left ventricle systolic dysfunction (EF \< 40 %)
- Patients with systolic blood pressure \< 85mm Hg
- Progressive cancer or considered cured for less than 5 years
- Patients with a known hypersensitivity to bosentan or any of the excipients
- Patients with HIV, HCV, HBV infection
- Patients with Liver disease Child-Pugh B and C
- Patients who are pregnant or breast-feeding
- Women of child-bearing age who are sexually active without practising reliable methods of contraception
- Patients who do not give informed consent
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01241383
Start Date
December 1 2010
End Date
June 1 2016
Last Update
July 6 2016
Active Locations (1)
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1
Pôle de médecine interne Centre de référence Maladies rares Groupe I Maladies systémiques et maladies auto-immunes rares en particulier Vascularites nécrosantes et les sclérodermies - Hôpital Cochin
Paris, France, 75014