At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 51 enrolled
Drug / intervention
Alphanate SD/HTdrug
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.
Phase IV A Study of Immunologic Safety for Alphanate in Previously Treated Patients Diagnosed With Severe Hemophilia A
In Brief
A Phase 4 clinical trial evaluating Alphanate SD/HT for Severe Hemophilia A. Completed, enrolled 51 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine the immunologic and overall safety associated with long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products other than Alphanate and who have no history of developing either antibody inhibitors to Factor VIII or nonspecific inhibitors of coagulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hemophilia A
CountriesPoland
Collaborators--
Timeline
Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2003
First PostedMay 2006
Primary CompletionDec 2018
Study CompletionDec 2018
TodayJul 2026
First PostedMay 10, 2006
Enrollment StartApr 8, 2003
Primary CompletionDec 11, 2018
Study CompletionDec 14, 2018
TodayJul 2, 2026
Enrollment to primary: 15.7 yearsPosted 20.1 years ago
Interventions
Alphanate SD/HTdrug
Plasma-derived preparation of Factor VIII