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Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00108758
First received: April 18, 2005
Last updated: January 11, 2017
Last verified: January 2017
  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
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 ]

Secondary Outcome Measures:
  • Efficacy variables

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   (Child, Adult, Senior)
Sexes 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

  Show 37 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00108758     History of Changes
Other Study ID Numbers: F7HAEM-1505
Study First Received: April 18, 2005
Last Updated: January 11, 2017

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

ClinicalTrials.gov processed this record on March 22, 2017