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

Completed · Phase 2

Conditions studied: Congenital Fibrinogen Deficiency, Afibrinogenemia

In brief

The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency

Key facts

Study ID

NCT01575756

Run by

Octapharma

People needed

22

Starts

2013-06-01

Expected to finish

2015-01-01

Last updated by the study team

2018-03-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 12 years.
• Documented congenital fibrinogen deficiency (afibrinogenemia).

You may not qualify if…

• Life expectancy > 6 month.
• Bleeding disorder other than congenital fibrinogen deficiency.
• Presence or history of hypersensitivity to study medication.
• Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment.
• Presence or history of arterial thrombosis with 1 year prior to enrollment.
• Hypersensitivity to human plasma products.
• Acute bleeding.
• Pregnant or currently breast-feeding women.
• Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery (if available).
• Blood or plasma donation in the 3 months prior to enrollment.
• Human immunodeficiency virus (HIV) positive with a viral load > 200 particles/µl or > 400000 copies/mL.
• End-stage liver disease.
• History of oesophageal varicose bleeding.

Where it is running

• University of Colorado Hemophilia & Thrombosis Center — Aurora, Colorado, United States
• Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• Specialized Hospital for Active Treatment "Joan Pavel" — Sofia, Bulgaria
• Department of Hematology St. John's Medical College Hospital — Bangalore, India
• Sahyadri Speciality Hospital — Prune, India
• Department of Hematology Christian Medical College — Vellore, India
• Nemazee Hospital Shiraz University of Medical Sciences — Shiraz, Iran
• Tehran University of Medical Sciences — Tehran, Iran
• Department of Hematology University Hospital — Zurich, Switzerland
• The Centre for Haemostatis and Thrombosis — London, United Kingdom

Full record on ClinicalTrials.gov

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