At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 58 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.
Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A
In Brief
A Phase 3 clinical trial evaluating Human cl rhFVIII for Severe Haemophilia A. Completed, enrolled 58 participants across 30 sites in 9 countries.
Detailed Summary
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Haemophilia A
CountriesCanada, Croatia, Finland, France, Japan, Netherlands, North Macedonia, Slovenia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartMay 2015
Primary CompletionSep 2018
TodayJul 2026
First PostedOct 6, 2014
Enrollment StartMay 1, 2015
Primary CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.7 years ago
Interventions
Human cl rhFVIIIbiological