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A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa

NCT02448680 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-02-25

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 or IX in 12 patients ( birth to \<6 years old), and 12 patients (≥6 years old to \<12 years old).

Conditions

  • Hemophilia A With Inhibitors
  • Hemophilia B With Inhibitors

Interventions

BIOLOGICAL

Coagulation FVIIa (Recombinant)

A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/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 or Factor IX

Sponsors & Collaborators

  • LFB USA, Inc.

    collaborator INDUSTRY

  • Laboratoire français de Fractionnement et de Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Michael Wang, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
11 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-07
Primary Completion
2017-06-30
Completion
2017-08-30

Countries

  • United States
  • Bulgaria
  • Czechia
  • Georgia
  • South Africa
  • Ukraine

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 NCT02448680 on ClinicalTrials.gov