At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 57 enrolled
Drug / intervention
Wilatedrug
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 Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Patients With Severe Hemophilia A
In Brief
A Phase 3 clinical trial evaluating Wilate for Severe Hemophilia A. Completed, enrolled 57 participants across 7 sites in 5 countries.
Detailed Summary
The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs, thus supplementing the existing database to obtain approval of Wilate for the indication hemophilia A in the USA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hemophilia A
CountriesBulgaria, Hungary, Poland, Romania, Russia
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionMar 2018
TodayJul 2026
First PostedNov 3, 2016
Enrollment StartDec 1, 2016
Primary CompletionMar 29, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.7 years ago
Interventions
Wilatedrug