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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00984126
The ClinicalTrials.gov registry entry for NCT00984126 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 199-participant average among 8 other Haemophilia A trials with a reported enrollment target. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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