stop_circleTerminated/Withdrawn

Hemophilia A

Bayer Identifier:

12112

ClinicalTrials.gov Identifier:

NCT00621673

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of the risk of inhibitor formation in previously treated patients with severe hemophilia A

Trial 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.

Key Participants Requirements

Sex

Male

Age

12 - 60 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
1
Trial Dates
May 2006 - November 2006
Phase
Phase 4
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hemophilia Treatment Center of Las VegasLas Vegas, 89109, United States
Terminated
Henry Ford Health SystemDetroit, 48202, United States

Primary Outcome

  • 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.
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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).
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Supportive Care
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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