A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease

PHASE3RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 27, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Von Willebrand Disease, Type 3
Interventions
DRUG

Emicizumab

"Participants will receive emicizumab 3 milligrams per kilogram (mg/kg) subcutaneous (SC) injections every week (QW) for the first 4 weeks as loading doses, followed by maintenance doses of emicizumab 3 mg/kg SC once every 2 weeks (Q2W).~During the extension period, participants may remain on maintenance dose of emicizumab 3 mg/kg Q2W, or change their emicizumab maintenance regimen to 1.5 mg/kg once every week (QW) or 6 mg/kg once every 4 weeks (Q4W), if they prefer and if agreed by the investigators."

DRUG

von Willebrand Factor (VWF) Concentrates

Used according to local labeling or local treatment guidelines.

DRUG

Factor VIII (FVIII) Concentrates

Used according to local labeling or local treatment guidelines.

DRUG

von Willebrand Factor (VWF) and Factor VIII (FVIII) Concentrates

Used according to local labeling or local treatment guidelines.

DRUG

Bypassing Agents

Used according to local labeling or local treatment guidelines.

Trial Locations (16)

3000

RECRUITING

UZ Leuven Gasthuisberg, Leuven

28046

RECRUITING

Hospital Universitario la Paz, Madrid

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

47051

RECRUITING

Gerinnungszentrum Rhein-Ruhr;Gerinnungsambulanz, Duisburg

50134

RECRUITING

AOU Careggi, Florence

53127

RECRUITING

Universitätsklinikum Bonn, Bonn

59037

RECRUITING

Hopital Claude Huriez - CHU Lille, Lille

60590

RECRUITING

Hämophiliezentrum Med. Klinik III/Institut für Transfusionsmedizin, Frankfurt/M.

75015

RECRUITING

Groupe Hospitalier Necker Enfants Malades, Paris

95817

RECRUITING

UC Davis, Sacramento

H4A 3J1

RECRUITING

McGill University Health Center, Montreal

Unknown

RECRUITING

IPS SURA Industriales Medellín, Medellín

00161

RECRUITING

Universita' Degli Studi La Sapienza-Ist.Di Ematologia, Rome

466-8560

RECRUITING

Nagoya University Hospital, Nagoya

3015 GD

RECRUITING

Erasmus MC, Rotterdam

02-776

RECRUITING

Instytut Hematologii i Transfuzjologii, Warsaw

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY