CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
rFVIII (BAY81-8973) on demand +2 morebiological
Likely dose
rFVIII (BAY81-8973) prophylaxis low-dose 30 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/NCT01233258
NCT01233258Phase 3Completed
CompareCT.gov

A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)

Bayer·interventional·Posted Nov 3, 2010·Updated Nov 28, 2016

In Brief

A Phase 3 clinical trial evaluating rFVIII (BAY81-8973) on demand, rFVIII (BAY81-8973) prophylaxis low-dose, and 1 other intervention for Hemophilia A. Completed, enrolled 80 participants across 47 sites in 18 countries.

Detailed Summary

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesArgentina, China, Colombia, Czechia, India, Indonesia, Japan, Mexico, Romania, Russia, Serbia, Slovakia, South Africa, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2010
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.7 years ago

Interventions

rFVIII (BAY81-8973) on demandbiological

Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization

rFVIII (BAY81-8973) prophylaxis low-dosebiological

Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.

rFVIII (BAY81-8973) prophylaxis high-dosebiological

Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.