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

Hemophilia A Clinical Trial

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 (Kogenate® FS).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00621673
• Other study ID #: 12112
• Status: Terminated
• Phase: Phase 4
• First received: February 12, 2008
• Last updated: December 17, 2014
• Start date: May 2006
• Est. completion date: October 2006

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• Kogenate (BAY 14-2222)
Antihemophilic factor (recombinant) 20-40 IU/ kg based on body weight of rFVIII, IV, 3 times a week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	Yes
Secondary	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.		6 months	Yes

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