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NCT01138501 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children 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
- 65
- Enrollment target
- 20
- Study locations
NCT01138501: Completed Phase 3 study of Haemophilia A and Congenital Bleeding Disorder, sponsored by Novo Nordisk A/S.
NCT01138501 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 65 participants, below the 217-participant average among 8 other Haemophilia A trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01138501, 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
- 65 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.
Primary Outcome
The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.
Conditions Studied
Interventions
- DRUG turoctocog alfa
Study Locations (20)
California
- Novo Nordisk Investigational Site - Orange
- Novo Nordisk Investigational Site - Torrance
Michigan
- Novo Nordisk Investigational Site - Detroit
- Novo Nordisk Investigational Site - East Lansing
New York
- Novo Nordisk Investigational Site - Brooklyn
- Novo Nordisk Investigational Site - Valhalla
Texas
- Novo Nordisk Investigational Site - Fort Worth
- Novo Nordisk Investigational Site - Houston
Arizona
- Novo Nordisk Investigational Site - Phoenix
Florida
- Novo Nordisk Investigational Site - Tampa
Georgia
- Novo Nordisk Investigational Site - Augusta
Iowa
- Novo Nordisk Investigational Site - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01138501 record still lists
NCT01138501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 217-participant average among 8 other Haemophilia A trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Haemophilia A appearing as the primary indexed condition, and to 1 intervention - of which turoctocog alfa is the first listed.
NCT01138501 names 20 study sites across 16 states, led by California, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT01138501 about?
NCT01138501 is a clinical study titled "Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A". This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.
What is the current status of trial NCT01138501?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2010-06. Estimated completion is 2011-11.
What conditions does trial NCT01138501 study?
This clinical trial studies the following conditions: Haemophilia A, Congenital Bleeding Disorder.
What interventions are being tested in trial NCT01138501?
The interventions under investigation include: turoctocog alfa (DRUG).
Who is sponsoring clinical trial NCT01138501?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01138501 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Haemophilia A
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 NCT01138501's enrollment target sits among peer trials
65 7th of 8 higher than 2 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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A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)
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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 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
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