Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

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

2010-05-31

Study Completion Date

2012-09-30

Brief Summary

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This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.

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Detailed Description

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Conditions

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Hemophilia A

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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Human-cl rhFVIII

Group Type EXPERIMENTAL

Human-cl rhFVIII

Intervention Type BIOLOGICAL

50 IU/kg for PK dose

Kogenate FS

Group Type ACTIVE_COMPARATOR

Kogenate FS

Intervention Type BIOLOGICAL

50 IU/kg for PK dose

Interventions

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Human-cl rhFVIII

50 IU/kg for PK dose

Intervention Type BIOLOGICAL

Kogenate FS

50 IU/kg for PK dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Severe hemophilia A (FVIII:C \<= 1%)
* Male subjects between 12 and 65 years of age
* Body weight 25 kg to 110 kg
* Previously treated with FVIII concentrate for at least 150 EDs