Trial of NovoSeven® in Haemophilia - Joint Bleeds
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00108797
First received: April 18, 2005
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors |
Drug: activated recombinant human factor VII Drug: Feiba VH |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | NovoSeven® (rFVIIa) by Single Dose for Home Treatment of Joint Bleeds in Haemophilia Patients With Inhibitors: A Pilot, Double-Blind Study Versus Standard Multiple Doses of NovoSeven® and Open-Label FEIBA® |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Comparison with FEIBA on review of pain, joint mobility and circumference [ Time Frame: after 1, 3, 6, and 9 hours of treatment, respectively ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety variables [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | September 2001 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108797
Locations
| United States, Arkansas | |
| Novo Nordisk Clinical Trial Call Center | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Los Angeles, California, United States, 90027 | |
| United States, Colorado | |
| Novo Nordisk Clinical Trial Call Center | |
| Aurora, Colorado, United States, 80010 | |
| United States, Indiana | |
| Novo Nordisk Clinical Trial Call Center | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Novo Nordisk Clinical Trial Call Center | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Novo Nordisk Clinical Trial Call Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Novo Nordisk Clinical Trial Call Center | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Novo Nordisk Clinical Trial Call Center | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Novo Nordisk Clinical Trial Call Center | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New Jersey | |
| Novo Nordisk Clinical Trial Call Center | |
| New Brunswick, New Jersey, United States, 08903 | |
| Novo Nordisk Clinical Trial Call Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New York | |
| Novo Nordisk Clinical Trial Call Center | |
| New York, New York, United States, 10029-6574 | |
| United States, North Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Chapel Hill, North Carolina, United States, 27599-7220 | |
| United States, Ohio | |
| Novo Nordisk Clinical Trial Call Center | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Pennsylvania | |
| Novo Nordisk Clinical Trial Call Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Novo Nordisk Clinical Trial Call Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Novo Nordisk Clinical Trial Call Center | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Michael Tillinger | Novo Nordisk |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00108797 History of Changes |
| Other Study ID Numbers: | F7HAEM-2068 |
| Study First Received: | April 18, 2005 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hemophilia B Hemophilia A Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemorrhage Hematologic Diseases |
Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013