Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

May 18, 2020

Study Completion Date

November 18, 2020

Conditions
Congenital AfibrinogenemiaCongenital Hypofibrinogenemia
Interventions
DRUG

BT524 (Part I)

Single intravenous infusion of 70 mg BT524 per kg body weight.

DRUG

BT524 (Part II)

Single or repetitive intravenous infusion(s) of BT524, depending on the severity of the disorder, location and extent of the bleeding and patient's clinical condition. Dosage based on individual body weight and fibrinogen level.

Trial Locations (6)

Unknown

Site 15, Sofia

Site 11, Cairo

Site 16, Frankfurt

Site 01, Beirut

Site 14, Sousse

Site12, Tunis

Sponsors
All Listed Sponsors
collaborator

ICON plc

INDUSTRY

collaborator

Phoenix Clinical Research

OTHER

collaborator

Accovion GmbH

INDUSTRY

lead

Biotest

INDUSTRY