Trials / Completed
CompletedNCT01913405
Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- Male
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PEGylated Recombinant factor VIII (rFVIII) | Lyophilized powder and solvent for solution for injection |
Timeline
- Start date
- 2013-12-20
- Primary completion
- 2016-09-23
- Completion
- 2016-09-23
- First posted
- 2013-08-01
- Last updated
- 2021-05-24
- Results posted
- 2018-05-14
Locations
22 sites across 9 countries: United States, Bulgaria, Lithuania, Netherlands, Russia, Spain, Switzerland, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01913405. Inclusion in this directory is not an endorsement.