Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01440946 · ClinicalTrials.gov registry record · Phase 3
Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B
A Phase 3 study, sponsored by Bioverativ Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT01440946 is a Phase 3 study that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 30 participants.
The verdict
NCT01440946, a Phase 3 study, has completed, sponsored by Bioverativ Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes
Interventions
- DRUG rFIXFc
- DRUG FIX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01440946
The ClinicalTrials.gov registry entry for NCT01440946 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which rFIXFc is the first listed.
NCT01440946 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01440946 about?
NCT01440946 is a clinical study titled "Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B". The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXF...
What is the current status of trial NCT01440946?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2012-06. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01440946?
The interventions under investigation include: rFIXFc (DRUG), FIX (DRUG).
Who is sponsoring clinical trial NCT01440946?
This trial is sponsored by Bioverativ Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.