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Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Suzhou, Jiangsu, 215006 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A
(FVIII activity: more than 5%, 1-5%, or less than 1%, respectively)

- Subjects with previous exposure to FVIII replacement therapy

- If human immunodeficiency virus (HIV) positive, documented cluster of differentiation
(CD4) count more than 200/µL within 6 months of study entry

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Diagnosed with any bleeding disorder in addition to hemophilia A

- Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of
the reporting laboratory)

- Subject has no history of exposure to FVIII products (previously untreated patient
[PUP])

- Subject is currently utilizing primary FVIII prophylaxis

- Subjects anticipating elective surgery that may be planned to occur in the 6 months
following study entry

- Treated with immunomodulatory therapy within 30 days prior to study entry or planned
use for the duration of their study participation

- Participated in another investigational drug or device study within 30 days prior to
study entry or planned participation for the duration of their study participation

- Subjects with a known hypersensitivity to hamster protein

- Significant hepatic or renal impairment (alanine aminotransferase [ALT] and aspartate
aminotransferase [AST] >5 x upper limit of normal [ULN], bilirubin >2 mg/dL or serum
creatinine >1.25 x ULN)

- Prothrombin Time >1.5 x ULN

- Platelet count

- Pregnant or breastfeeding women

- Unwilling or unable to follow the terms of the protocol

- Any condition which may compromise the subject's ability to comply with and/or perform
study-related activities or that poses a clinical contraindication to study
participation, in the opinion of the Investigator or Sponsor

NCT00868530
Pfizer
Completed
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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