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

NCT00621673 | Terminated Phase 4

• 1 other identifier: 12112
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemophilia A

Keywords

Hemophilia A,; Inhibitor formation,; rFVIII

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Arm 1

OTHER

Drug: Kogenate (BAY 14-2222)

Interventions

Kogenate (BAY 14-2222) DRUG

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

Arm 1

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Detroit, Michigan, 48202, United States

Location

Unknown Facility

Las Vegas, Nevada, 89109, United States

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, human; BAY 14-2222

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: May 1, 2006
• Study Completion: October 1, 2006
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (2)