Trials / Completed
CompletedNCT02585960
BAX 855 PK-guided Dosing
Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%) 2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PEGylated Recombinant Factor VIII | Pharmacokinetic (PK) evaluation |
| BIOLOGICAL | PEGylated Recombinant Factor VIII | Standard treatment |
| BIOLOGICAL | PEGylated Recombinant Factor VIII | Intensified treatment |
Timeline
- Start date
- 2015-11-23
- Primary completion
- 2018-08-05
- Completion
- 2018-08-05
- First posted
- 2015-10-26
- Last updated
- 2021-05-25
- Results posted
- 2019-08-26
Locations
83 sites across 22 countries: United States, Australia, Austria, Bulgaria, France, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Norway, Poland, Romania, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02585960. Inclusion in this directory is not an endorsement.