EUCTR2011-001785-17-RO
Active, not recruiting
Not Applicable
Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Octapharma AG
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Evaluable completion of study GENA\-03 by having a study participation period of 6 months, provided that prophylaxis with Human\-cl rhFVIII is continued without intermediate interruption.
- •2\.Voluntarily given, fully informed written and signed consent obtained from the parents (or legal guardians) before any study\-related procedures are conducted. The need for obtaining assent will depend on the subjects’ developmental stage and intellectual capacity.
- •3\.Capability to understand and comply with the relevant aspects of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Development of FVIII inhibitors (\=0\.6 Bethesda units \[BU]) in the course of study GENA\-03\.
- •2\.Any severe liver or kidney disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \>5 times of upper limit of normal, creatinine \>120 µmol/L).
Outcomes
Primary Outcomes
Not specified
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