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Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen

NCT01757405 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-05-11

Study results available
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Summary

The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.

Conditions

Interventions

BIOLOGICAL

Recombinant Factor VIIa BI (rFVIIa BI)

Administered approximately every 3 hours as an intravenous bolus injection on-demand

BIOLOGICAL

Recombinant Factor VIIa BI (rFVIIa BI)

Administered as a single intravenous bolus injection on-demand

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-02-20
Primary Completion
2014-11-11
Completion
2014-11-11

Countries

  • United States
  • Japan
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT01757405 on ClinicalTrials.gov