Trials / Completed
CompletedNCT01945593
BAX 855 Continuation
A Phase 3b Continuation Study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients With Severe Hemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
Summary
To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BAX855 | Antihemophilic Factor (Recombinant), PEGylated |
Timeline
- Start date
- 2013-10-15
- Primary completion
- 2018-03-02
- Completion
- 2018-03-02
- First posted
- 2013-09-18
- Last updated
- 2021-05-24
- Results posted
- 2019-05-01
Locations
89 sites across 23 countries: United States, Australia, Austria, Bulgaria, Czechia, Germany, Hong Kong, Israel, Japan, Lithuania, Malaysia, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01945593. Inclusion in this directory is not an endorsement.