Terminated/Withdrawn

Hemophilia A

Bayer Identifier:

12112

ClinicalTrials.gov Identifier:

NCT00621673

EudraCT Number:

Not Available

EU CT Number:

Not Available

Assessment of the risk of inhibitor formation in previously treated patients with severe hemophilia A

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.

Key Participants Requirements

Sex

Male

Age

12 - 60 Years

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

May 2006 - November 2006

Phase

Phase 4

Could I Receive a placebo

Products

Kogenate FS (Recombinant Factor VIII, BAY14-2222)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Hemophilia Treatment Center of Las Vegas	Las Vegas, 89109, United States
Terminated	Henry Ford Health System	Detroit, 48202, United States

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.
Time Frame:
6 months
Safety Issue:
yes

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.
Time Frame:
6 months
Safety Issue:
yes

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

Additional Information

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