CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9 enrolled
Drug / intervention
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) +1 moredrug
Likely dose
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) 5 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.

Search/NCT00666406
NCT00666406Phase 4Completed
CompareCT.gov

Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A: a Phase IV, Prospective, Randomized, Controlled, Cross-over, Single Center Study

Baxalta now part of Shire·interventional·Posted Apr 24, 2008·Updated May 19, 2021

In Brief

A Phase 4 clinical trial evaluating Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) and Recombinant Factor VIII (rAHF) for Hemophilia A. Completed, enrolled 9 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2008
Enrollment StartMar 31, 2008
Primary CompletionFeb 18, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.2 years ago

Interventions

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)drug

Infusion of 50 +/- 5 IU/kg bodyweight

Recombinant Factor VIII (rAHF)drug

Infusion of 50 +/- 5 IU/kg bodyweight