Trials / Terminated
TerminatedNCT01271868
Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Medexus Pharma, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and control of hemorrhaging during prophylaxis) of IB1001 in previously treated pediatric subjects with hemophilia B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IB1001 |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2011-01-07
- Last updated
- 2021-03-15
- Results posted
- 2019-04-11
Locations
10 sites across 3 countries: United States, India, United Kingdom
Source: ClinicalTrials.gov record NCT01271868. Inclusion in this directory is not an endorsement.