Clinical trial NCT01790828: Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A
Official title: Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha 'Registered' In Subjects With Hemophilia A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemophilia A

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

Detailed description: non probability sample

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants by Family History of Factor VIII Inhibitor
timeFrame: 4 years
Secondary outcomes:
measure: Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)
timeFrame: 4 years
measure: Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age
timeFrame: 4 years
measure: 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
timeFrame: 4 years
measure: Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)
timeFrame: 4 years
measure: 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
timeFrame: 4 years
measure: 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
timeFrame: 4 years
measure: Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy
timeFrame: 4 years
measure: Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)
timeFrame: 4 years
measure: Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age
timeFrame: 4 years
measure: Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age
timeFrame: 4 years
measure: Percentage of Participants Experiencing Hemorrhages During Prophylaxis
timeFrame: 4 years
measure: Annualized Bleeding Rates During Prophylaxis
timeFrame: 4 years
measure: Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha
timeFrame: 4 years
measure: Average Infusion Dose During Prophylaxis (All Participants)
timeFrame: 4 years
measure: Average Infusion Dose During Prophylaxis in Participants <18 Years of Age
timeFrame: 4 years
measure: Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age
timeFrame: 4 years
measure: Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)
timeFrame: 4 years
measure: Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age
timeFrame: 4 years
measure: Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age
timeFrame: 4 years
Other outcomes:
Locations:
city: Guro-gu
country: Korea, Republic of
facility: Yonsei Rehabilitation Clinic
state: Seoul
city: Songpa-gu
country: Korea, Republic of
facility: Kim Hugh Chul Internal Medicine Clinic
state: Seoul
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: