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Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00108758
First received: April 18, 2005
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Drug: activated recombinant human factor VII
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Reduction of bleeds [ Time Frame: During 3 months treatment period as compared to 3 months observation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy variables [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion Criteria:

  • Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108758

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Berkeley, California, United States, 94704
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Iowa City, Iowa, United States, 52242
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19104
Argentina
Ciudad Autónoma de Bs. As., Argentina, C1425ASU
Brazil
Campinas, Sao Paulo, Brazil, 13081970
Bulgaria
Sofia, Bulgaria, 1756
Philippines
Manila, Philippines
Poland
Warszawa, Poland, 00-791
Romania
Bucharest, Romania, 011155
Russian Federation
Moscow, Russian Federation, 105077
South Africa
Johannesburg, Gauteng, South Africa, 2193
Spain
Sevilla, Spain, 41013
Turkey
Bornova-IZMIR, Turkey, 35100
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Ute Friedrich, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00108758     History of Changes
Other Study ID Numbers: F7HAEM-1505
Study First Received: April 18, 2005
Last Updated: October 23, 2013
Health Authority: Bulgaria: Ministry of Health
Spain: Spanish Agency of Medicines
Russia: Pharmacological Committee, Ministry of Health
Turkey: Ministry of Health
Brazil: National Health Surveillance Agency
Poland: Ministry of Health
Romania: State Institute for Drug Control
South Africa: Medicines Control Council
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Philippines: Bureau of Food and Drugs
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemorrhage
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014