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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

Intervention: Kogenate (BAY 14-2222) (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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.

Clinical Details

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 (KogenateŽ FS).

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

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.

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.


Minimum age: 12 Years. Maximum age: 60 Years. Gender(s): Male.


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


- 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

Locations and Contacts

Detroit, Michigan 48202, United States

Las Vegas, Nevada 89109, United States

Additional Information

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Starting date: May 2006
Last updated: December 17, 2014

Page last updated: August 23, 2015

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