Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease.

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

June 22, 2020

Primary Completion Date

February 24, 2023

Study Completion Date

February 24, 2023

Conditions
Telangiectasia, Hereditary HemorrhagicRendu Osler Disease
Interventions
DRUG

Nintedanib 150 mg and 100 mg soft capsules

Nintedanib 150 mg soft capsules twice daily approximately 12 hours apart (i.e. 300 mg/day) for 12 weeks. In case of adverse reaction a dose reduction at 200 mg/day (100 mg twice daily) can be prescribe.

DRUG

Oral treatment of placebo soft capsule

Placebo soft capsules (identical to 150 mg and 100 mg soft capsules)

Trial Locations (8)

Unknown

CHU d'Angers, Angers

Hôpital Femme-Mère-Enfant-Centre de Référence pour la maladie de Rendu-Osler, Bron

CHU Clermont Ferrand, Clermont-Ferrand

CHU de Marseille-Hôpital la conception, Marseille

CHU de Montpellier-Hôpital St Eloi, Montpellier

Hôpital Tenon, Paris

CHRU - Hôpital J.Bernard, Poitiers

CHU de Rennes-Hôpital Pontchaillou, Rennes

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03954782 - Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease. | Biotech Hunter | Biotech Hunter