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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01712438 |
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Date of registration:
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18/10/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
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Scientific title:
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Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01712438 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Belarus
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Canada
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France
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Georgia
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Germany
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India
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Italy
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Moldova, Republic of
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Morocco
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Poland
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Portugal
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Russian Federation
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Slovenia
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Spain
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Sigurd Knaub |
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Address:
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Telephone:
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Email:
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Affiliation:
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Octapharma |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male patients
- Severe Hemophilia A (FVIII:C <1%)
- No previous treatment with FVIII concentrates or other blood products containing FVIII
Exclusion Criteria:
- Diagnosis with a coagulation disorder other than Hemophilia A
- Severe liver or kidney disease
- Concomitant treatment with any systemic immunosuppressive drug
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Severe Hemophilia A
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Intervention(s)
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Biological: Human cl rhFVIII
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Primary Outcome(s)
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Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
[Time Frame: maximum 5 years (100 exposure days)]
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Secondary Outcome(s)
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Efficacy of Human-cl rhFVIII for the Treatment of Bleeds
[Time Frame: Maximum 5 years (100 exposure days)]
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Frequency of Spontaneous Break-through Bleeds
[Time Frame: Maximum 5 years (100 exposure days)]
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Efficacy of Human-cl rhFVIII for Surgical Prophylaxis
[Time Frame: Maximum 5 years (100 exposure days)]
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Secondary ID(s)
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2012-002554-23
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GENA-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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