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NCT02141074 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients 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
- 54
- Enrollment target
- 20
- Study locations
NCT02141074: Completed Phase 3 study of Congenital Bleeding Disorder and Haemophilia B, sponsored by Novo Nordisk A/S.
NCT02141074 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 54 participants, below the 132-participant average among 8 other Congenital Bleeding Disorder trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02141074, 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
- 54 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
Primary Outcome
Number of participants with incidence of inihibitory antibodies against FIX after 50 ED is presented and defined as an inhibitory antibody titre greater than equal to 0.6 Bethesda unit (BU) at two consecutive tests performed at the central laboratory and also tested positive for nonacog beta pegol binding antibodies.
Conditions Studied
Interventions
- DRUG nonacog beta pegol
Study Locations (20)
California
- Miller Children's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Endocrinology - Los Angeles
Florida
- Shands Hospital at the University of Florida - Gainesville
- Nemours Chld Clnc Jacksonville - Jacksonville
Georgia
- Augusta University - Augusta
- Hope for Kids - Macon
North Carolina
- University of North Carlolina-Chapel Hill - Chapel Hill
- Novant Hlth Vasc Ins Charlotte - Charlotte
Ohio
- Univ Hosp Cleveland Med Ctr - Cleveland
- Dayton Children Hemostati Ctr - Dayton
Pennsylvania
- Penn State MS Hershey Med Ctr - Hershey
- St Christopher Hosp for Child - Philadelphia
Idaho
- St. Luke's Mountain States Tumor Institute - Boise
Iowa
- University Of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2014-07-02 |
| Est. Completion | 2022-10-27 |
| Phase | Phase 3 |
What the finished NCT02141074 record still lists
NCT02141074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 132-participant average among 8 other Congenital Bleeding Disorder trials with a reported enrollment target (59% 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.
NCT02141074 names 20 study sites across 14 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02141074 about?
NCT02141074 is a clinical study titled "Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B". This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
What is the current status of trial NCT02141074?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2014-07-02. Estimated completion is 2022-10-27.
What conditions does trial NCT02141074 study?
This clinical trial studies the following conditions: Congenital Bleeding Disorder, Haemophilia B.
What interventions are being tested in trial NCT02141074?
The interventions under investigation include: nonacog beta pegol (DRUG).
Who is sponsoring clinical trial NCT02141074?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02141074 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Iowa. 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 NCT02141074's enrollment target sits among peer trials
54 6th of 8 higher than 3 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
-
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
COMPLETED · Phase 3
-
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
COMPLETED · Phase 3
-
Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
COMPLETED · Phase 3
-
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
COMPLETED · Phase 3
-
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
-
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
COMPLETED
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