Status:
COMPLETED
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
Lead Sponsor:
Pfizer
Conditions:
Hemophilia A
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00868530
Start Date
September 1 2008
End Date
December 1 2009
Last Update
June 12 2025
Active Locations (6)
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1
Pfizer Investigational Site
Suzhou, Jiangsu, China, 215006
2
Pfizer Investigational Site
Heping District, Tianjin Municipality, China, 300020
3
Pfizer Investigational Site
Hangzhou, Zhejiang, China, 310003
4
Pfizer Investigational Site
Beijing, China, 100730