At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 37 enrolled
Drug / intervention
Moroctocog alfa ( AF-CC) +1 morebiological
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.
A Non-randomized, Open-label Study To Evaluate The Pharmacokinetics, Safety And Efficacy Of Refacto Af In Previously Treated Pediatric Subjects Less Than Twelve Years Of Age With Severe Hemophilia A (Fviii:c <1%).
In Brief
A Phase 4 clinical trial evaluating Moroctocog alfa ( AF-CC) and Laboratory tests for Hemophilia A. Completed, enrolled 37 participants across 17 sites in 9 countries.
Detailed Summary
The study will be investigating pharmacokinetics, safety and efficacy in patients less than 12 years of age with severe hemophilia A that have been previously treated with Factor VIII products ( including blood products).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesFinland, Georgia, Italy, Romania, Serbia, Spain, Sweden, Turkey (Türkiye), Ukraine
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartDec 2009
Primary CompletionMar 2016
Study CompletionApr 2016
TodayJul 2026
First PostedJun 5, 2009
Enrollment StartDec 1, 2009
Primary CompletionMar 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.1 years ago
Interventions
Moroctocog alfa ( AF-CC)biological
Dosing is at the discretion of the Investigator
Laboratory testsprocedure
Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody