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

Primary Purpose

Hemophilia A

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Kogenate (BAY 14-2222)

About this trial

This is an interventional supportive care trial for Hemophilia A focused on measuring Hemophilia A,, Inhibitor formation,, rFVIII

Eligibility Criteria

12 Years - 60 Years (Child, Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00621673

First Posted

February 12, 2008

Last Updated

December 17, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00621673

Brief Title

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

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).

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Study Start Date

May 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

Keywords

Hemophilia A,, Inhibitor formation,, rFVIII

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Kogenate (BAY 14-2222)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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