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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621673
Recruitment Status : Terminated
First Posted : February 22, 2008
Last Update Posted : December 18, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Hemophilia A Drug: Kogenate (BAY 14-2222) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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).
Study Start Date : May 2006
Actual Study Completion Date : October 2006

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00621673

United States, Michigan
Detroit, Michigan, United States, 48202
United States, Nevada
Las Vegas, Nevada, United States, 89109
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00621673     History of Changes
Other Study ID Numbers: 12112
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Hemophilia A,
Inhibitor formation,

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII