At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
Human-cl rhFVIII +1 morebiological
Likely dose
Human-cl rhFVIII 50 IUfrom 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 Human-cl rhFVIII, a Newly Developed Human Cell-line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A
In Brief
A Phase 2 clinical trial evaluating Human-cl rhFVIII and Kogenate FS for Hemophilia A. Completed, enrolled 22 participants across 9 sites in 3 countries.
Detailed Summary
This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesBulgaria, Germany, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartMay 2010
Primary CompletionOct 2011
Study CompletionSep 2012
TodayJul 2026
First PostedOct 2, 2009
Enrollment StartMay 1, 2010
Primary CompletionOct 1, 2011
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.8 years ago
Interventions
Human-cl rhFVIIIbiological
50 IU/kg for PK dose
Kogenate FSbiological
50 IU/kg for PK dose