At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 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.
Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A
In Brief
A Phase 3 clinical trial evaluating Human cl rhFVIII for Severe Hemophilia A. Completed, enrolled 110 participants across 37 sites in 17 countries.
Detailed Summary
Investigate 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
CountriesBelarus, Canada, France, Georgia, Germany, India, Italy, Moldova, Morocco, Poland, Portugal, Russia, Slovenia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartFeb 2013
Primary CompletionDec 2018
Study CompletionDec 2019
TodayJul 2026
First PostedOct 23, 2012
Enrollment StartFeb 1, 2013
Primary CompletionDec 14, 2018
Study CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.7 years ago
Interventions
Human cl rhFVIIIbiological