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Clinical Trials/EUCTR2008-001563-11-BG
EUCTR2008-001563-11-BG
Active, not recruiting
Not Applicable

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.

Octapharma AG0 sites22 target enrollmentMarch 15, 2011
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DrugsKogenate Bayer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Octapharma AG
Enrollment
22
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 15, 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Must have severe hemophilia A (FVIII:C \<1%).
  • •Male subjects greater/equal 12 and less or equal than 65 years of age.
  • •Body weight 25 kg to 110 kg.
  • •Previously treated with FVIII concentrate, at least 150 EDs.
  • •Immunocompetent (CD4\+ count \>200/µL)
  • •Negative for anti\-HIV; if positive, viral load \<200 particles/µL or \<400,000 copies/mL.
  • •Freely given written informed consent.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •Other coagulation disorder than hemophilia A.
  • •Present or past FVIII inhibitor activity (\>0\.6 BU).
  • •Severe liver or kidney disease (ALT and AST levels \>5 times of upper limit of normal, creatinine \>120 µmol/L).
  • •Receiving or scheduled to receive immuno\-modulating drugs (other than anti\-retroviral chemotherapy) such as alpha\-interferon, prednisone (equivalent to \>10 mg/day), or similar drugs.
  • •Participation in another interventional clinical study currently or during the past month.

Outcomes

Primary Outcomes

Not specified

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