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Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901

Sponsor
Baxalta now part of Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00157053
Collaborator
(none)
82
Enrollment
24
Locations
32.4
Actual Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.

Condition or Disease Intervention/Treatment Phase
  • Drug: Antihemophilic factor, recombinant, manufactured protein-free
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study
Actual Study Start Date :
Nov 22, 2001
Actual Primary Completion Date :
Aug 3, 2004
Actual Study Completion Date :
Aug 3, 2004

Outcome Measures

Primary Outcome Measures

  1. Terminal phase half-life for Recombinant Antihemophilic Factor (rAHF-PFM) [Within 30 minutes prior to the pharmacokinetic infusion and at 1 hour ± 5 minutes, 9 ± 1 hour, 24 ± 2 hours, and 48 ± 2 hours after the infusion.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Subject has completed Baxter protocol 069901

  • Subject is HIV-1 seronegative or, if HIV-1 seropositive, has a CD4+ lymphocyte count

= 400/mm3 documented within three months of the screening visit

  • Subject (and his legally acceptable representative, in the case of study participants

= 10 and < 18 years of age) has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter

Exclusion Criteria:

  • The subject received factor VIII products other than rAHF-PFM upon completion of Baxter protocol 069901

  • The subject developed an inhibitor to factor VIII, measured in the central laboratory, during Baxter protocol 069901. An inhibitor is defined as a Bethesda titer > 1.0 or, if Bethesda titer < 1.0, confirmation using the Nijmegen modification of the Bethesda assay with a titer > 0.6

  • The subject is scheduled to receive an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids) during the course of the study

  • The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mountain States Regional Hemophilia and Thrombosis Center Aurora Colorado United States 80045
2 Childrens Healthcare of Atlanta Blood Bank Atlanta Georgia United States 30322
3 Comprehensive Bleeding Disorders Center Peoria Illinois United States 61614
4 Indiana Hemophilia & Thrombosis Center Indianapolis Indiana United States 46260
5 Michigan State University East Lansing Michigan United States 48824
6 University of Medicine & Dentistry of New Jersey New Brunswick New Jersey United States 08903-0019
7 Cornell Medical Center New York New York United States 10021
8 Mt. Sinai Medical School New York New York United States 10029
9 Children's Hospital Medical Center Pharmacy Cincinnati Ohio United States 45229
10 Hemophilia Center of Western Pennsylvania Pittsburgh Pennsylvania United States 15213-4306
11 Puget Sound Blood Center Seattle Washington United States 98104-1256
12 Allgemeines Krankenhaus der Stadt Wien Vienna Austria 1090
13 KU Leuven Universitaire Ziekenhuizen Leuven Belgium 3000
14 University of Alberta Calgary Alberta Canada 470 MSB
15 Hôpital Edouard Herriot Lyon France 69437
16 Klinikum der J. W. Goethe - Universität Frankfurt am Main Germany 60590
17 Medizinische Hochschule Hannover Hannover Germany 30623
18 Klinikum Innenstadt der Universität München Munich Germany D-80336
19 Ospedale Maggiore di Milano Milan Italy 20122
20 University Hospital MAS Malmö Sweden S-20502
21 The Royal Free Hospital London England United Kingdom NW3 2QG
22 Central Manchester Healthcare NHS Trust Manchester England United Kingdom M13 9WL
23 The Churchill Hospital Oxford England United Kingdom OX3 7LJ
24 University Hospital of Wales Cardiff Wales United Kingdom CF4 4XW

Sponsors and Collaborators

  • Baxalta now part of Shire

Investigators

  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Baxalta now part of Shire
ClinicalTrials.gov Identifier:
NCT00157053
Other Study ID Numbers:
  • 060102
First Posted:
Sep 12, 2005
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Keywords provided by Baxalta now part of Shire
Factor VIII Deficiency
Additional relevant MeSH terms:
Hemophilia A
Factor VIII

Study Results

No Results Posted as of Aug 24, 2021