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Clinical Trials/EUCTR2009-011055-43-AT
EUCTR2009-011055-43-ATActive, not recruitingNot Applicable

Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A

Octapharma AG0 sites32 target enrollmentStarted: May 19, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
32
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Male

Inclusion Criteria

  • •Severe haemophilia A (FVIII:C less/equal 1%).·
  • •Male subjects greater/equal 12 years of age.·
  • •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? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Other coagulation disorder than haemophilia A.·
  • •Present or past FVIII inhibitor activity (>0.6 BU).·
  • •Severe liver or kidney disease (ALAT and ASAT 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. ·
  • •Participation in any other study with human-cl rhFVIII.

Investigators

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