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Clinical Trials/ISRCTN90038418
ISRCTN90038418
Completed
Not Applicable

Clinical study to investigate the long-term safety and efficacy of human cell line recombinant Factor VIII (human-cl rhFVIII) in previously treated patients with severe haemophilia A

Octapharma AG (Switzerland)0 sites22 target enrollmentNovember 16, 2009
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ConditionsSevere haemophilia AHaematological DisordersHereditary factor VIII deficiency

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe haemophilia A
Sponsor
Octapharma AG (Switzerland)
Enrollment
22
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 16, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Octapharma AG (Switzerland)

Eligibility Criteria

Inclusion Criteria

  • •1\. Must have severe haemophilia A (FVIII:C less than 1%; historical value as documented in subject records)
  • •2\. Aged greater than 18 years and less than 65 years, male only
  • •3\. Body weight 45 kg to 110 kg
  • •4\. Previously treated with human\-cl rhFVIII (within study GENA\-09\)
  • •6\. Negative for human immunodeficiency virus (HIV) or respective viral load less than 200 particles/µL
  • •7\. Freely given written informed consent

Exclusion Criteria

  • •1\. Other coagulation disorder than haemophilia A
  • •2\. Present or past FVIII inhibitor activity (greater than 0\.6 BU)
  • •3\. Severe liver or kidney disease (alanine aminotransferase \[ALAT] and aspartate aminotransferase \[ASAT] levels greater than 5 times of upper limit of normal, creatinine greater than 120 µmol/L)
  • •4\. Receiving or scheduled to receive immuno\-modulating drugs (other than anti\-retroviral chemotherapy) such as alpha\-interferon, prednisone (equivalent to greater than 10 mg/day), or similar drugs
  • •5\. Participation in another clinical study currently or during the past month, except GENA\-09

Outcomes

Primary Outcomes

Not specified

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