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

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Baxalta

Status and phase

Completed
Phase 3
Phase 2

Conditions

Hemophilia A

Treatments

Drug: Antihemophilic factor, recombinant, manufactured protein-free

Study type

Interventional

Funder types

Industry

Identifiers

NCT00157053
060102

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

Male

Ages

10+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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