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

Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
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

Summary

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 KogenateŽ-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: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: The primary outcome is 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.

Eligibility

Minimum age: 10 Years. Maximum age: 60 Years. Gender(s): Male.

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

- Written informed consent by subject and parent/legal representative, if < 18 years

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

Locations and Contacts

Detroit, Michigan 48202, United States

Las Vegas, Nevada 89109, United States

Additional Information

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Starting date: May 2006
Ending date: October 2006
Last updated: June 2, 2008

Page last updated: June 20, 2008

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