CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 82 enrolled
Drug / intervention
Antihemophilic factor, recombinant, manufactured protein-free +1 moredrug
Likely dose
Standard prophylaxis: 20–40 IU/kg every 48±6 hours; PK-driven prophylaxis: 20–80 IU/kg every 72±6 hoursAI-extracted
Key inclusion· 8
  • ✓Severe or moderately severe hemophilia A with baseline factor VIII level ≤2% of normal
  • ✓At least 150 documented exposure days to factor VIII concentrates
  • ✓Age 7 to 65 years
  • ✓Karnofsky performance score >60
Key exclusion· 10
  • ✕Known hypersensitivity to factor VIII concentrates or mouse/hamster proteins
  • ✕History of factor VIII inhibitors with titer ≥0.6 BU at any time prior to screening
  • ✕Detectable factor VIII inhibitor at screening with titer ≥0.4 BU (Nijmegen assay)
  • ✕Severe chronic liver disease (INR >1.4, hypoalbuminemia, portal hypertension, esophageal varices)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00243386
NCT00243386Phase 4Completed
CompareCT.gov

Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (ADVATE rAHF-PFM): A Phase 4 Study Comparing Two Prophylactic Regimens in Subjects With Severe or Moderately Severe Hemophilia A

Baxalta now part of Shire·interventional·Posted Oct 24, 2005·Updated May 19, 2021

In Brief

A Phase 4 clinical trial evaluating Antihemophilic factor, recombinant, manufactured protein-free for Hemophilia A. Completed, enrolled 82 participants across 29 sites in 10 countries.

Detailed Summary

The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6 hours; actual dose determined by Baxter utilizing an algorithm and the patient's pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled patients will be treated originally on demand for a period of 6 months and then they will be randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of 12 months +/- 2 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustria, Czechia, Greece, Hungary, Italy, Poland, Russia, Slovenia, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 24, 2005
Enrollment StartJan 4, 2006
Primary CompletionJun 16, 2010
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.7 years ago

Interventions

Antihemophilic factor, recombinant, manufactured protein-freedrug

Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator

Antihemophilic factor, recombinant, manufactured protein-freedrug

PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data