At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 48 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.
Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
In Brief
A Phase 3 clinical trial evaluating Human-cl rhFVIII for Severe Hemophilia A. Completed, enrolled 48 participants across 15 sites in 9 countries.
Detailed Summary
The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hemophilia A
CountriesCanada, France, Georgia, India, Moldova, Poland, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartApr 2014
Primary CompletionDec 2018
TodayJul 2026
First PostedNov 25, 2013
Enrollment StartApr 1, 2014
Primary CompletionDec 27, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 12.6 years ago
Interventions
Human-cl rhFVIIIbiological