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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ClinicalTrials.gov Identifier: NCT00157053 |
Recruitment Status
:
Completed
First Posted
: September 12, 2005
Last Update Posted
: October 23, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemophilia A | Drug: Antihemophilic factor, recombinant, manufactured protein-free | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 |
Study Start Date : | November 2001 |
Actual Study Completion Date : | August 2004 |


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Ages Eligible for Study: | 10 Years and older (Child, Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157053

Principal Investigator: | Michael Tarantino, MD | Comprehensive Bleeding Disorder Center, Peoria, Illinois, USA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00157053 History of Changes |
Other Study ID Numbers: |
060102 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | October 23, 2017 |
Last Verified: | February 2011 |
Keywords provided by Shire:
Factor VIII Deficiency |
Additional relevant MeSH terms:
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Factor VIII Coagulants |