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Completed

NCT Number: NCT01790828

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

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

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei Rehabilitation Clinic, Guro-gu, Seoul, South Korea

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About this study

non probability sample

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xyntha : coagulation factor IIIV (recombinant)

Drug

Xyntha will be administered according to physician's discretion.

Other names: Xyntha, MOROCTOCOG ALFA

Primary outcomes

  1. Percentage of Participants by Family History of Factor VIII Inhibitor

    Time frame: 4 years

Secondary outcomes

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

    Time frame: 4 years

  2. 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

  3. 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

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

    Time frame: 4 years

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

  5. 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

    Time frame: 4 years

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

  6. 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

    Time frame: 4 years

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

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

    Time frame: 4 years

    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.

  8. Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)

    Time frame: 4 years

  9. Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age

    Time frame: 4 years

  10. Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age

    Time frame: 4 years

  11. Percentage of Participants Experiencing Hemorrhages During Prophylaxis

    Time frame: 4 years

  12. Annualized Bleeding Rates During Prophylaxis

    Time frame: 4 years

    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)]

  13. Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha

    Time frame: 4 years

    Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.

  14. Average Infusion Dose During Prophylaxis (All Participants)

    Time frame: 4 years

  15. Average Infusion Dose During Prophylaxis in Participants <18 Years of Age

    Time frame: 4 years

  16. Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age

    Time frame: 4 years

  17. Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)

    Time frame: 4 years

  18. Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age

    Time frame: 4 years

  19. Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2013
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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