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

Tracking Information

First Received Date ^ICMJE

February 12, 2008

Last Updated Date

June 29, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00621673 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

Brief 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 Kogenate-FS raised in a Baby Hamster Kidney cell line.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Drug: Kogenate (BAY 14-2222)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

12 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00621673

Responsible Party

Medical Affairs Therapeutic Area Head, Bayer HealthCare AG

Study ID Numbers ^ICMJE

12112

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP