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

Brief Title

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

Official Title

Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study

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.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Terminal phase half-life for Recombinant Antihemophilic Factor (rAHF-PFM)

Condition

Hemophilia A

Intervention

Antihemophilic factor, recombinant, manufactured protein-free

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

November 22, 2001

Completion Date

August 3, 2004

Primary Completion Date

August 3, 2004

Eligibility Criteria

        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

Gender

Male

Ages

10 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Study Director, ,

Location Countries

Austria

Location Countries

Austria

Administrative Informations

NCT ID

NCT00157053

Organization ID

Responsible Party

Sponsor

Study Sponsor

Baxalta now part of Shire

Study Sponsor

Study Director, Study Director, Takeda

Verification Date

August 2021