Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A

December 17, 2014 updated by: Bayer

Assessment of the Risk of Inhibitor Formation in Subjects With Severe Hemophilia A When Switched From a Replacement Therapy With a rFVIII Produced by a Chinese Hamster Ovary (CHO) Cell Line to a rFVIII Produced by a Baby Hamster Kidney (BHK) Cell Line (Kogenate® FS).

Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

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
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Nevada
      • Las Vegas, Nevada, United States, 89109

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

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subjects with severe hemophilia A (< 2% FVIII:C)
  • Subjects with no history of FVIII inhibitor antibody formation
  • Subjects with no measurable inhibitor activity
  • Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in the previous 6 months
  • Subjects whose current treatment with any CHO rFVIII product
  • Subjects with no elective surgery and/or continuous infusion FVIII administration is foreseen during the study
  • Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT) compatible with FVIII deficiency

Exclusion Criteria:

  • Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's disease)
  • Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS or known hypersensitivity to mouse or hamster proteins
  • Any individual with a past history of severe reaction(s) to FVIII concentrates
  • Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry
  • Subjects who were receiving or had received other experimental drugs within 3 months prior to study entry
  • Subjects who require any medication for FVIII infusions

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Drug: Kogenate (BAY 14-2222)
Antihemophilic factor (recombinant) 20-40 IU/ kg based on body weight of rFVIII, IV, 3 times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate whether a switch of replacement therapy from an rFVIII produced in a CHO cell line to an rFVIII produced in a BHK cell line is associated with a risk of inhibitor formation.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To quantify the risk of inhibitor formation, to assess the efficacy of the rFVIII-FS while on regular replacement therapy and to assess the quality-of-life (QoL) before and after the study.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Bayer

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

May 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12112 (Research Ethic committee of Maisonneuve Rosemont Hospital)

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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