Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00621673

Purpose

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.

Condition	Intervention	Phase
Hemophilia A	Drug: Kogenate (BAY 14-2222)	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	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).

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	4
Study Start Date:	May 2006
Study Completion Date:	October 2006

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	12 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621673

Locations

United States, Michigan

Detroit, Michigan, United States, 48202
United States, Nevada

Las Vegas, Nevada, United States, 89109

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	12112
Study First Received:	February 12, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00621673 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Bayer:

Hemophilia A,
Inhibitor formation,
rFVIII

Additional relevant MeSH terms:

Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A

ClinicalTrials.gov processed this record on November 27, 2009