Trials / Completed
CompletedNCT00716716
Phase I/IIa Study of FIXFc in Hemophilia B Patients
A Phase I/IIa Safety and Pharmacokinetic Study of Intravenous FIXFc in Previously Treated Hemophilia B Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Bioverativ Therapeutics Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.
Detailed description
This study was previously posted by Syntonix Pharmaceuticals, Inc. In January, 2007, sponsorship of the trial was transferred to Biogen Idec. In February, 2017, sponsorship of the trial was transferred to Bioverativ.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rFIXFc | As specified in the treatment arm |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2008-07-16
- Last updated
- 2020-12-19
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00716716. Inclusion in this directory is not an endorsement.