Trials / Completed
CompletedNCT01233258
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rFVIII (BAY81-8973) on demand | 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 |
| BIOLOGICAL | rFVIII (BAY81-8973) prophylaxis low-dose | 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. |
| BIOLOGICAL | rFVIII (BAY81-8973) prophylaxis high-dose | 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. |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2010-11-03
- Last updated
- 2016-11-28
- Results posted
- 2014-02-11
Locations
47 sites across 18 countries: United States, Argentina, China, Colombia, Czechia, India, Indonesia, Japan, Mexico, Romania, Russia, Serbia, Slovakia, South Africa, Taiwan, Thailand, Turkey (Türkiye), Ukraine
Source: ClinicalTrials.gov record NCT01233258. Inclusion in this directory is not an endorsement.