Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/17/2018 |
| Start Date: | June 2013 |
| End Date: | January 2015 |
A Prospective, Controlled, Randomised, Crossover Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan® P/RiaSTAPTM in Patients With Congenital Fibrinogen Deficiency
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
and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital
fibrinogen deficiency
Inclusion Criteria:
- Age ≥ 12 years.
- Documented congenital fibrinogen deficiency (afibrinogenemia).
Exclusion Criteria:
- 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.
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