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

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00621673
First received: February 12, 2008
Last updated: October 14, 2010
Last verified: October 2010
History of Changes
  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 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:

MedlinePlus related topics: Hemophilia
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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00621673     History of Changes
Other Study ID Numbers: 12112
Study First Received: February 12, 2008
Last Updated: October 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Hemophilia A,
Inhibitor formation,
rFVIII

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
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013