Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors (ProFEIBA)

February 13, 2020 updated by: Tulane University School of Medicine

A Prospective, Randomized, Cross-over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors

The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hemophilia A, any severity, with documented history of high-titer inhibitor (>5BU); current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; >/= 6 bleeds requiring bypassing therapy in the previous 6 months

Exclusion Criteria:

  • concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: On-demand first
Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
Drug: activated prothrombin complex concentrate (FEIBA)

FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months

FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months
Other: Prophylaxis first
Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
Drug: activated prothrombin complex concentrate (FEIBA)

FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months

FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Bleeds During 6 Month Treatment Period
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University School of Medicine

Investigators

  • Principal Investigator: Cindy A Leissinger, Tulane University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-FEIBA Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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