Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

N/ACompletedNCT01790828

Pfizer42 enrolled

Overview

This study is to describe the safety and efficacy of Xyntha® during the usual care setting.

non probability sample

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hemophilia A

Interventions

Xyntha : coagulation factor IIIV (recombinant)DRUG

Xyntha will be administered according to physician's discretion.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement). * Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha. Exclusion Criteria: * Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product. * Patients with a known history of hypersensitivity to hamster protein. * Patients participating in an interventional trial of any investigational drug or device.

Locations (4)

Yonsei Rehabilitation Clinic

Guro-gu, Seoul, South Korea

Kim Hugh Chul Internal Medicine Clinic

Songpa-gu, Seoul, South Korea

Pusan National University Hospital

Busan, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Outcomes

Primary Outcomes

Percentage of Participants by Family History of Factor VIII Inhibitor

Time frame: 4 years

Secondary Outcomes

Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)

Time frame: 4 years

Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age

Time frame: 4 years

Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age

Time frame: 4 years

Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)

Response categories were excellent, good, moderate, or no response.

Time frame: 4 years

Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age

Response categories were excellent, good, moderate, or no response.

Time frame: 4 years

Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age

Response categories were excellent, good, moderate, and no response.

Time frame: 4 years

Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy

Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy.

Data from ClinicalTrials.gov

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