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Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor

NCT00851721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-05-19

Study results available
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Summary

The purpose of the study was to determine the efficacy, safety, and health-related quality of life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment.

Conditions

  • Hemophilia A or B With Inhibitors
  • Hemophilia A
  • Hemophilia B

Interventions

BIOLOGICAL

Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)

85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period

BIOLOGICAL

Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)

FEIBA NF dose and dosing interval as prescribed by the treating physician

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-10-17
Completion
2012-10-17

Countries

  • United States
  • Brazil
  • Bulgaria
  • Croatia
  • Japan
  • New Zealand
  • Poland
  • Romania
  • Russia
  • 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 NCT00851721 on ClinicalTrials.gov