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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01138501
The ClinicalTrials.gov registry entry for NCT01138501 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 8 other Haemophilia A trials with a reported enrollment target (70% lower). 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.
NCT01138501 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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