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

NCT ID: NCT00621673

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-10-31

Brief Summary

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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

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Conditions

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Hemophilia A

Keywords

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Hemophilia A, Inhibitor formation, rFVIII

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type OTHER

Kogenate (BAY 14-2222)

Intervention Type DRUG

Antihemophilic factor (recombinant) 20-40 IU/ kg based on body weight of rFVIII, IV, 3 times a week

Interventions

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Kogenate (BAY 14-2222)

Antihemophilic factor (recombinant) 20-40 IU/ kg based on body weight of rFVIII, IV, 3 times a week

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Detroit, Michigan, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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12112

Identifier Type: -

Identifier Source: org_study_id