At a glance
ClinicalIndex Comparison Record- ✓Severe hemophilia A with baseline factor VIII activity <1% of normal (tested at screening after minimum 3-day washout)
- ✓Documented history of at least 150 exposure days to factor VIII concentrates (plasma-derived or recombinant)
- ✓Age 12 to 65 years
- ✓Karnofsky performance score >60
- ✕Known hypersensitivity to mouse or hamster proteins or factor VIII concentrates
- ✕History of factor VIII inhibitors with titer ≥0.8 BU (Bethesda Assay) or ≥0.4 BU (Nijmegen modification) at any time prior to screening
- ✕Detectable factor VIII inhibitor at screening (≥0.4 BU by Nijmegen modification)
- ✕Severe chronic liver disease (INR >1.4, hypoalbuminemia, portal hypertension, splenomegaly, or history of esophageal varices)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (ADVATE rAHF-PFM): A Phase 4 Study to Determine the Pharmacokinetic Response of Patients Diagnosed With Severe Hemophilia A to Different Doses of ADVATE rAHF-PFM
In Brief
A Phase 4 clinical trial evaluating Antihemophilic factor, recombinant, manufactured protein-free for Hemophilia A. Completed, enrolled 38 participants across 8 sites.
Detailed Summary
The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase \[IU/dL\] per IU/kg infused) and major single-infusion pharmacokinetic parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not have received treatment with a factor VIII concentrate for at least 3 days. Blood samples will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion. A washout period of at least 3 days, but no more than 30 days between the last blood draw and the next infusion will be observed. During participation, subjects will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII concentrate. A secondary objective is to investigate the relationship between pharmacokinetic parameters at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and von Willebrand factor antigen at baseline.
Study Details
Timeline
Interventions
15 IU/kg rAHF-PFM
30 IU/kg rAHF-PFM
50 IU/kg rAHF-PFM