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

This study has been terminated.
Information provided by (Responsible Party):
Bayer Identifier:
First received: February 12, 2008
Last updated: December 17, 2014
Last verified: December 2014

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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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).

Resource links provided by NLM:

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: 1
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


Ages Eligible for Study:   12 Years to 60 Years
Genders 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
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT00621673     History of Changes
Other Study ID Numbers: 12112
Study First Received: February 12, 2008
Last Updated: December 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Hemophilia A,
Inhibitor formation,

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Factor VIII
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 09, 2015