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Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors

NCT02020369 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-06-14

Study results available
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Summary

The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX

Conditions

  • Hemophilia A With Inhibitors
  • Hemophilia B With Inhibitors

Interventions

BIOLOGICAL

Coagulation Factor VIIa (Recombinant)

A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX

Sponsors & Collaborators

  • Laboratoire français de Fractionnement et de Biotechnologies

    collaborator INDUSTRY

  • rEVO Biologics

    lead INDUSTRY

Principal Investigators

  • Jean Francois Schved, MD · Saint Eloi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • United States
  • Belarus
  • Bulgaria
  • Georgia
  • Israel
  • Poland
  • Romania
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02020369 on ClinicalTrials.gov