Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

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The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.

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Detailed Description

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Conditions

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Severe Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Human-cl rhFVIII

Recombinant FVIII derived from a human cell line.

Group Type EXPERIMENTAL

Human-cl rhFVIII

Intervention Type BIOLOGICAL

Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery.

Interventions

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Human-cl rhFVIII

Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrollment into GENA-11

Exclusion Criteria

* Development of FVIII inhibitors (\<=0.6 BU), during the course of the GENA-01 study
* Development of any severe liver or kidney disease (ALT and AST level \> 5 times of upper limit of normal, creatine \>120 micro mol/L) during the course of the GENA-01 study

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No