At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3 enrolled
Drug / intervention
Human-cl rhFVIIIbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study to Investigate the Long-Term Efficacy, Safety and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A - Extension Study to GENA-01
In Brief
A Phase 3 clinical trial evaluating Human-cl rhFVIII for Severe Hemophilia A. Completed, enrolled 3 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hemophilia A
CountriesBulgaria, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartJun 2011
Primary CompletionAug 2012
TodayJul 2026
First PostedApr 26, 2011
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.2 years ago
Interventions
Human-cl rhFVIIIbiological
Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery.