Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

Pfizer

Status and phase: Completed; Phase 3

Conditions: Hemophilia A

Treatments: Biological: Xyntha

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868530

3082B2-3316

B1831015

Details and patient eligibility

About

This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.

Enrollment: 53 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Xyntha

Experimental group

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.

Treatment:

Biological: Xyntha