Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00108758
Recruitment Status : Completed
First Posted : April 19, 2005
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

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 or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors Drug: activated recombinant human factor VII Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2004
Primary Completion Date : November 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hemophilia
U.S. FDA Resources

Primary Outcome Measures :
  1. Reduction of bleeds [ Time Frame: During 3 months treatment period as compared to 3 months observation period ]

Secondary Outcome Measures :
  1. Efficacy variables

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00108758

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

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S Identifier: NCT00108758     History of Changes
Other Study ID Numbers: F7HAEM-1505
First Posted: April 19, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

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