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Clinical Trials/EUCTR2011-001785-17-CZ
EUCTR2011-001785-17-CZ
Active, Not Recruiting
Phase 1

Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII

Octapharma AG0 sites60 target enrollmentOctober 7, 2011
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ConditionsSevere Haemophilia AMedDRA version: 14.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Severe Haemophilia A
Sponsor
Octapharma AG
Enrollment
60
Status
Active, Not Recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 7, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

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: 60
  • •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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