Trials / Completed
CompletedNCT02716194
BAX 826 Dose-Escalation Safety Study
A Phase 1, Prospective, Open Label, Two Period, Fixed Sequence, Dose-Escalation Study of the PK and Safety of BAX 826 (PSA-rFVIII) in Previously Treated Patients With Severe (FVIII <1%) Hemophilia A
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
1. To assess tolerability and safety of BAX 826 after a single infusion in previously treated patients (PTPs) with severe hemophilia A 2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE 3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BAX 826 | |
| BIOLOGICAL | Octocog alfa |
Timeline
- Start date
- 2016-03-03
- Primary completion
- 2017-01-17
- Completion
- 2017-01-17
- First posted
- 2016-03-23
- Last updated
- 2021-05-25
- Results posted
- 2018-09-20
Locations
28 sites across 9 countries: Bulgaria, Germany, Hungary, Italy, Netherlands, Poland, Russia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02716194. Inclusion in this directory is not an endorsement.