Trials / Completed
CompletedNCT02210091
BAX 855 Pediatric Study
A Phase 3 Prospective, Uncontrolled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity of BAX 855 (PEGylated Full-length Recombinant FVIII) in Previously Treated Pediatric Patients With Severe Hemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 11 Years
- Healthy volunteers
- Not accepted
Summary
The study purpose is: * To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last. * To compare pharmacokinetic (PK) parameters to ADVATE. * To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes. * To evaluate safety and immunogenicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method | Pharmacokinetic (PK) analysis of ADVATE |
| BIOLOGICAL | PEGylated Recombinant Factor VIII | Pharmacokinetic (PK) analysis of BAX 855 |
| BIOLOGICAL | PEGylated Recombinant Factor VIII | Prophylaxis treatment |
Timeline
- Start date
- 2014-10-31
- Primary completion
- 2015-10-23
- Completion
- 2015-10-23
- First posted
- 2014-08-06
- Last updated
- 2021-05-24
- Results posted
- 2016-12-05
Locations
39 sites across 11 countries: United States, Bulgaria, Hong Kong, Malaysia, Netherlands, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02210091. Inclusion in this directory is not an endorsement.