Trials / Terminated
TerminatedNCT02895945
BAX 802 in CHA With Inhibitors
A Phase 3, Multicenter, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects With Congenital Hemophilia A With Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- Male
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802) | In case of major surgery, FVIII target level is ≥80% for major surgeries/ procedures and ≥50% for minor surgeries/ procedures. |
Timeline
- Start date
- 2016-12-22
- Primary completion
- 2021-01-22
- Completion
- 2021-01-22
- First posted
- 2016-09-12
- Last updated
- 2021-10-20
- Results posted
- 2021-10-20
Locations
24 sites across 12 countries: United States, Bulgaria, Canada, Germany, Italy, Netherlands, Norway, Poland, Russia, South Africa, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02895945. Inclusion in this directory is not an endorsement.