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NOT YET RECRUITING
NCT06957002
PHASE2

Bosentan in the Treatment of Giant Cell Arteritis

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether a treatment with 3 months of bosentan associated to standard therapy might be superior to glucocorticoids alone in term of failure free survival at 12 months

Official title: Bosentan in the Treatment of Giant Cell Arteritis. Multicenter, Randomized, Controlled, Superiority Phase II Trial Comparing a Combination of Bosentan and Glucocorticoids Versus Glucocorticoids Alone in the Treatment of Patients With GCA

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09

Completion Date

2029-09

Last Updated

2025-05-14

Healthy Volunteers

No

Interventions

DRUG

Bosentan

Bosentan : 62.5 mg twice a day for 4 weeks and 125 mg twice a day during 9 weeks (treatment length 3 months)

DRUG

Glucocorticoids

prespecified GC tapering schedule

Locations (1)

Unité de Recherche Clinique, Entrepôts de données et Pharmacologie GHU Paris Centre

Paris, France