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

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).

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00621673

Enrollment

Registered

2008-02-22

Start date

2006-05-31

Completion date

2006-10-31

Last updated

2014-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Hemophilia A,, Inhibitor formation,, rFVIII

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.

Interventions

DRUGKogenate (BAY 14-2222)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

12 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026