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NCT00984126 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Haemophilia A and Congenital Bleeding Disorder, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
- 20
- Study locations
NCT00984126: Completed Phase 3 study of Haemophilia A and Congenital Bleeding Disorder, sponsored by Novo Nordisk A/S.
NCT00984126 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 214 participants, roughly in line with the 199-participant average among 8 other Haemophilia A trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00984126, 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
- 214 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients. The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).
Primary Outcome
The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial.
Conditions Studied
Interventions
- DRUG turoctocog alfa
Study Locations (20)
Other
- Novo Nordisk Investigational Site - Rio de Janeiro
- Novo Nordisk Investigational Site - Split
- Novo Nordisk Investigational Site - Zagreb
- Novo Nordisk Investigational Site - Berlin
Ohio
- Novo Nordisk Investigational Site - Cincinnati
- Novo Nordisk Investigational Site - Dayton
São Paulo
- Novo Nordisk Investigational Site - Campinas
- Novo Nordisk Investigational Site - São Paulo
Arizona
- Novo Nordisk Investigational Site - Phoenix
California
- Novo Nordisk Investigational Site - Long Beach
Florida
- Novo Nordisk Investigational Site - Tampa
Georgia
- Novo Nordisk Investigational Site - Atlanta
Iowa
- Novo Nordisk Investigational Site - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2009-10-26 |
| Est. Completion | 2016-06-29 |
| Phase | Phase 3 |
What the finished NCT00984126 record still lists
NCT00984126 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 199-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 is the first listed.
NCT00984126 names 20 study sites across 15 states, led by Other, Ohio, São Paulo.
Frequently Asked Questions
What is clinical trial NCT00984126 about?
NCT00984126 is a clinical study titled "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". This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients. The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and ...
What is the current status of trial NCT00984126?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2009-10-26. Estimated completion is 2016-06-29.
What conditions does trial NCT00984126 study?
This clinical trial studies the following conditions: Haemophilia A, Congenital Bleeding Disorder.
What interventions are being tested in trial NCT00984126?
The interventions under investigation include: turoctocog alfa (DRUG).
Who is sponsoring clinical trial NCT00984126?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00984126 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 NCT00984126's enrollment target sits among peer trials
214 3rd of 8 higher than 6 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.
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