Efficacy and Safety Study of Human-cl rhFVIII in PTPs 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

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-31

Brief Summary

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This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.

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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

PREVENTION

Blinding Strategy

NONE

Study Groups

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human cl-rhFVIII

Group Type EXPERIMENTAL

recombinant Factor VIII

Intervention Type BIOLOGICAL

intravenous infusion of factor FVIII every other day.

Interventions

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recombinant Factor VIII

intravenous infusion of factor FVIII every other day.

Intervention Type BIOLOGICAL

Other Intervention Names

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human-cl rhFVIII

Eligibility Criteria

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Inclusion Criteria

* Severe hemophilia A ((FVIII:C \<= 1%)
* Male subjects \>= 12 years of age
* Previously treated with FVIII concentrate, at least 50 EDs
* Immunocompetent (CD4+ count \> 200/ul)
* Negative for anti- HIV; if positive, viral load \< 200 particles/u; or \<400,000 copies/mL

Exclusion Criteria

* Other coagulation disorder than hemophilia A
* Present of past FVIII inhibitor activity (.= 0.6 BU)
* Severe liver and kidney disease
* Receiving of scheduled to receive immuno-modulating drugs

Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No