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Efficacy of NovoSeven in Bleeding Prophylaxis in Hemophilia - Article


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Hemophilia




Clinical Trial: Efficacy of NovoSeven in Bleeding Prophylaxis in Hemophilia

This study is currently recruiting patients.

Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk

Purpose

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 Treatment or Intervention Phase
Hemophilia A
Hemophilia B
 Drug: NovoSeven
Phase II

MedlinePlus related topics:  Bleeding Disorders;   Blood and Blood Disorders;   Genetic Disorders;   Hemophilia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Efficacy
Expected Total Enrollment:  1680

Study start: March 2004;  Expected completion: December 2005
Last follow-up: October 2005;  Data entry closure: November 2005

Eligibility

Ages Eligible for Study:  2 Years and above,  Genders Eligible for Study:  Both

Criteria

  • Ages Eligible for Study: 2 Years and older

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00108758

Novo Nordisk Clinical Trial Call Center      866-867-7178 

California
      Berkeley,  California,  94704,  United States; Recruiting

      Orange,  California,  92868,  United States; Recruiting

Illinois
      Chicago,  Illinois,  60612,  United States; Recruiting

Indiana
      Indianapolis,  Indiana,  46260,  United States; Recruiting

Iowa
      Iowa City,  Iowa,  52242,  United States; Recruiting

Louisiana
      New Orleans,  Louisiana,  70112,  United States; Recruiting

Massachusetts
      Boston,  Massachusetts,  02115,  United States; Recruiting

Michigan
      Detroit,  Michigan,  48201,  United States; Recruiting

New Jersey
      Newark,  New Jersey,  07112,  United States; Recruiting

New York
      New Hyde Park,  New York,  11040,  United States; Recruiting

Pennsylvania
      Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

      Philadelphia,  Pennsylvania,  19134,  United States; Recruiting

Texas
      Houston,  Texas,  77030,  United States; Recruiting

More Information

Study ID Numbers:  F7HAEM-1505
Record last reviewed:  April 2005
Last Updated:  April 18, 2005
Record first received:  April 18, 2005
ClinicalTrials.gov Identifier:  NCT00108758
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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December 1, 2008



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