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NCT01480180 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Haemophilia A and Congenital Bleeding Disorder, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 186
- Enrollment target
- 20
- Study locations
NCT01480180: Completed Phase 3 study of Haemophilia A and Congenital Bleeding Disorder, sponsored by Novo Nordisk A/S.
NCT01480180 is a Phase 3 study of Haemophilia A and Congenital Bleeding Disorder that has completed, run by Novo Nordisk A/S. The registered enrollment target is 186 participants, roughly in line with the 202-participant average among 8 other Haemophilia A trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01480180, a Phase 3 study of Haemophilia A and Congenital Bleeding Disorder, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 186 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.
Primary Outcome
All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all parti
Conditions Studied
Interventions
- DRUG turoctocog alfa pegol
Study Locations (20)
California
- Novo Nordisk Investigational Site - Long Beach
- Novo Nordisk Investigational Site - Sacramento
- Novo Nordisk Investigational Site - Torrance
District of Columbia
- Novo Nordisk Investigational Site - Washington D.C.
- Novo Nordisk Investigational Site - Washington D.C.
Florida
- Novo Nordisk Investigational Site - Orlando
- Novo Nordisk Investigational Site - Tampa
Michigan
- Novo Nordisk Investigational Site - Detroit
- Novo Nordisk Investigational Site - East Lansing
New Jersey
- Novo Nordisk Investigational Site - New Brunswick
- Novo Nordisk Investigational Site - Newark
Arizona
- Novo Nordisk Investigational Site - Phoenix
Georgia
- Novo Nordisk Investigational Site - Augusta
Idaho
- Novo Nordisk Investigational Site - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2012-01-30 |
| Est. Completion | 2018-12-10 |
| Phase | Phase 3 |
What the finished NCT01480180 record still lists
NCT01480180 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 202-participant average among 8 other Haemophilia A trials with a reported enrollment target.
The record links to 2 conditions, with Haemophilia A appearing as the primary indexed condition, and to 1 intervention - of which turoctocog alfa pegol is the first listed.
NCT01480180 names 20 study sites across 14 states, led by California, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT01480180 about?
NCT01480180 is a clinical study titled "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". This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.
What is the current status of trial NCT01480180?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2012-01-30. Estimated completion is 2018-12-10.
What conditions does trial NCT01480180 study?
This clinical trial studies the following conditions: Haemophilia A, Congenital Bleeding Disorder.
What interventions are being tested in trial NCT01480180?
The interventions under investigation include: turoctocog alfa pegol (DRUG).
Who is sponsoring clinical trial NCT01480180?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01480180 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01480180's enrollment target sits among peer trials
186 5th of 8 higher than 4 of 8 other Haemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Haemophilia A 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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