Brief Title
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
Official Title
An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With Xyntha (B Domain Deleted Recombinant Factor VIII, Albumin Free) In Chinese Subjects With Hemophilia A
Brief Summary
This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion
Secondary Outcome
FVIII Recovery : Change From Baseline in FVIII Concentration
Condition
Hemophilia A
Intervention
Xyntha
Study Arms / Comparison Groups
Xyntha
Description: This trial was an open-label and included assessments of safety, clinical efficacy, and Factor VIII (FVIII) recovery in Chinese subjects with hemophilia A. Subjects received on-demand treatments with Xyntha over a 6-month (calendar day) period.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
53
Start Date
September 2008
Completion Date
December 2009
Primary Completion Date
December 2009
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
Gender
All
Ages
6 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00868530
Organization ID
3082B2-3316
Secondary IDs
B1831015
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
March 2017