Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Congenital Fibrinogen DeficiencyAfibrinogenemia
Interventions
BIOLOGICAL

Octafibrin

Octafibrin was supplied as a powder for reconstitution with water for injection.

BIOLOGICAL

Haemocomplettan® P or RiaSTAPTM

Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.

Trial Locations (10)

11040

Cohen Children's Medical Center of New York, New Hyde Park

80045

University of Colorado Hemophilia & Thrombosis Center, Aurora

Unknown

"Specialized Hospital for Active Treatment Joan Pavel", Sofia

Department of Hematology St. John's Medical College Hospital, Bangalore

Sahyadri Speciality Hospital, Prune

Department of Hematology Christian Medical College, Vellore

Nemazee Hospital Shiraz University of Medical Sciences, Shiraz

Tehran University of Medical Sciences, Tehran

Department of Hematology University Hospital, Zurich

The Centre for Haemostatis and Thrombosis, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY