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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Congenital Fibrinogen Deficiency Afibrinogenemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Octafibrin followed by Haemocomplettan® P or RiaSTAPTM

Participants received Octafibrin 70 mg/kg intravenously once followed by Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once 45 days later.

Group Type EXPERIMENTAL

Octafibrin

Intervention Type BIOLOGICAL

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

Haemocomplettan® P or RiaSTAPTM

Intervention Type BIOLOGICAL

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

Haemocomplettan® P or RiaSTAPTM followed by Octafibrin

Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once followed by Octafibrin 70 mg/kg intravenously once 45 days later.

Group Type EXPERIMENTAL

Octafibrin

Intervention Type BIOLOGICAL

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

Haemocomplettan® P or RiaSTAPTM

Intervention Type BIOLOGICAL

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

Interventions

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Octafibrin

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

Intervention Type 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Plasma derived fibrinogen concentrate Plasma derived fibrinogen concentrate

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No