Trial Condition(s):
Hemophilia A
Assessment of the risk of inhibitor formation in previously treated patients with severe hemophilia A
Bayer Identifier:
12112
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hemophilia Treatment Center of Las Vegas Las Vegas, United States, 89109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Henry Ford Health System Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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.Timeframe: 6 months
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.Timeframe: 6 months
Additional Information
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