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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00108797
Other study ID # F7HAEM-2068
Secondary ID
Status Completed
Phase Phase 4
First received April 18, 2005
Last updated January 11, 2017
Start date September 2001
Est. completion date February 2006

Study information

Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
eptacog alfa (activated)

Feiba VH


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Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Young G, Shafer FE, Rojas P, Seremetis S. Single 270 microg kg(-1)-dose rFVIIa vs. standard 90 microg kg(-1)-dose rFVIIa and APCC for home treatment of joint bleeds in haemophilia patients with inhibitors: a randomized comparison. Haemophilia. 2008 Mar;14 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison with FEIBA on review of pain, joint mobility and circumference after 1, 3, 6, and 9 hours of treatment, respectively No
Secondary Safety variables No
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