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

Primary Purpose

Hemophilia A With Inhibitors

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

activated prothrombin complex concentrate (FEIBA)

About this trial

This is an interventional prevention trial for Hemophilia A With Inhibitors

Eligibility Criteria

24 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tulane University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

On-demand first

Prophylaxis first

Arm Description

Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug

Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug

Outcomes

Primary Outcome Measures

Number of Bleeds During 6 Month Treatment Period

Secondary Outcome Measures

Full Information

NCT ID

NCT00221195

First Posted

September 19, 2005

Last Updated

February 13, 2020

Sponsor

Tulane University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00221195

Brief Title

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

Acronym

ProFEIBA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tulane University School of Medicine

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A With Inhibitors

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

On-demand first

Arm Type

Other

Arm Description

Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug

Arm Title

Prophylaxis first

Arm Type

Other

Arm Description

Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug

Intervention Type

Drug

Intervention Name(s)

activated prothrombin complex concentrate (FEIBA)

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Bleeds During 6 Month Treatment Period

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cindy A Leissinger

Organizational Affiliation

Tulane University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tulane University School of Medicine

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23731246

Citation

Gringeri A, Leissinger C, Cortesi PA, Jo H, Fusco F, Riva S, Antmen B, Berntorp E, Biasoli C, Carpenter S, Kavakli K, Morfini M, Negrier C, Rocino A, Schramm W, Windyga J, Zulfikar B, Mantovani LG. Health-related quality of life in patients with haemophilia and inhibitors on prophylaxis with anti-inhibitor complex concentrate: results from the Pro-FEIBA study. Haemophilia. 2013 Sep;19(5):736-43. doi: 10.1111/hae.12178. Epub 2013 Jun 4.

Results Reference

derived

PubMed Identifier

22047559

Citation

Leissinger C, Gringeri A, Antmen B, Berntorp E, Biasoli C, Carpenter S, Cortesi P, Jo H, Kavakli K, Lassila R, Morfini M, Negrier C, Rocino A, Schramm W, Serban M, Uscatescu MV, Windyga J, Zulfikar B, Mantovani L. Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors. N Engl J Med. 2011 Nov 3;365(18):1684-92. doi: 10.1056/NEJMoa1104435. Erratum In: N Engl J Med. 2011 Dec 22;365(25):2441.

Results Reference

derived

Learn more about this trial

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

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