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

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

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

Study Overview

• Status: Completed
• Conditions: Hemophilia A
• Intervention / Treatment: Drug: Xyntha : coagulation factor IIIV (recombinant)

Detailed Description

non probability sample

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 632-739
    • Pusan National University Hospital
  • Seoul, Korea, Republic of, 134-727
    • Kyung Hee University Hospital at Gangdong
  • Seoul
    • Guro-gu, Seoul, Korea, Republic of, 152-834
      • Yonsei Rehabilitation Clinic
    • Songpa-gu, Seoul, Korea, Republic of, 138-879
      • Kim Hugh Chul Internal Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hemophilia A

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Xyntha group; Xyntha will be administered according to physician's discretion.	Drug: Xyntha : coagulation factor IIIV (recombinant); Xyntha will be administered according to physician's discretion.; Other Names: Xyntha, MOROCTOCOG ALFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants by Family History of Factor VIII Inhibitor	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)		4 years
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age		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		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.	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.	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.	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.	4 years
Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)		4 years
Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age		4 years
Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age		4 years
Percentage of Participants Experiencing Hemorrhages During Prophylaxis		4 years
Annualized Bleeding Rates During Prophylaxis	Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) [(total period of date of bleeding)/365.25)]	4 years
Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha	Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.	4 years
Average Infusion Dose During Prophylaxis (All Participants)		4 years
Average Infusion Dose During Prophylaxis in Participants <18 Years of Age		4 years
Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age		4 years
Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)		4 years
Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age		4 years
Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age		4 years

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: July 21, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A; Coagulants; Factor VIII
• Other Study ID Numbers: B1831078