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NCT01467427 · ClinicalTrials.gov registry record · Phase 3
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
A Phase 3 study of Congenital Bleeding Disorder and Haemophilia B, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
- 20
- Study locations
NCT01467427: Completed Phase 3 study of Congenital Bleeding Disorder and Haemophilia B, sponsored by Novo Nordisk A/S.
NCT01467427 is a Phase 3 study of Congenital Bleeding Disorder and Haemophilia B that has completed, run by Novo Nordisk A/S. The registered enrollment target is 25 participants, below the 136-participant average among 8 other Congenital Bleeding Disorder trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01467427, a Phase 3 study of Congenital Bleeding Disorder and Haemophilia B, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.
Primary Outcome
Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of participants who developed inhibitory antibodies against factor IX are reported.
Conditions Studied
Interventions
- DRUG nonacog beta pegol
Study Locations (20)
Ohio
- Univ Hosp Cleveland Med Ctr - Cleveland
- Nationwide Children's Hospital - Columbus
- Dayton Children Hemostati Ctr - Dayton
California
- Children's Hospital Los Angeles - Endocrinology - Los Angeles
- UC Davis Medical Center - Sacramento
Georgia
- Emory University_Atlanta_1 - Atlanta
- Augusta University - Augusta
New York
- Maimonides Medical Center - Brooklyn
- Mount Sinai Medical Center - New York
Colorado
- Colorado Hemophilia & Thrombosis Center - Aurora
District of Columbia
- Childrens National Medical Ctr - Washington D.C.
Florida
- University of Miami Hospital & Clinics - Miami
Iowa
- University Of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2012-05-16 |
| Est. Completion | 2023-11-17 |
| Phase | Phase 3 |
What the finished NCT01467427 record still lists
NCT01467427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 136-participant average among 8 other Congenital Bleeding Disorder trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Congenital Bleeding Disorder appearing as the primary indexed condition, and to 1 intervention - of which nonacog beta pegol is the first listed.
NCT01467427 names 20 study sites across 15 states, led by Ohio, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01467427 about?
NCT01467427 is a clinical study titled "Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.". This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.
What is the current status of trial NCT01467427?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2012-05-16. Estimated completion is 2023-11-17.
What conditions does trial NCT01467427 study?
This clinical trial studies the following conditions: Congenital Bleeding Disorder, Haemophilia B.
What interventions are being tested in trial NCT01467427?
The interventions under investigation include: nonacog beta pegol (DRUG).
Who is sponsoring clinical trial NCT01467427?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01467427 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Bleeding Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01467427's enrollment target sits among peer trials
25 7th of 8 higher than 2 of 8 other Congenital Bleeding Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Bleeding Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
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Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
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Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
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Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
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Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
COMPLETED · Phase 3
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Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
COMPLETED
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