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Clinical Trials/NCT00108758
NCT00108758
Completed
Phase 2

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

Novo Nordisk A/S1 site in 1 country23 target enrollmentMarch 2004
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ConditionsCongenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors
Drugsactivated recombinant human factor VII

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Congenital Bleeding Disorder
Sponsor
Novo Nordisk A/S
Enrollment
23
Locations
1
Primary Endpoint
Reduction of bleeds
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2004
End Date
November 2005
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Reduction of bleeds

Time Frame: During 3 months treatment period as compared to 3 months observation period

Secondary Outcomes

  • Efficacy variables

Study Sites (1)

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