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Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
CompletedPhase 3
Sponsor: Pfizer
Conditions: Hemophilia A
Interventions: Xyntha
Countries: China
This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.
Eligibility overview
Sex: ALL
Age: 6 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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: * 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 \<80,000 / µL * 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
Locations (6)
- Suzhou, Jiangsu, China
- Heping District, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Beijing, China
- Guangzhou, China
- Shanghai, China