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

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ClinicalTrials.gov Identifier: NCT01790828
Recruitment Status : Completed
First Posted : February 13, 2013
Results First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Hemophilia A Drug: Xyntha : coagulation factor IIIV (recombinant)

Detailed Description:
non probability sample

Study Type : Observational
Actual Enrollment : 42 participants
Time Perspective: Prospective
Official Title: Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha 'Registered' In Subjects With Hemophilia A
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014


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 Name: Xyntha, MOROCTOCOG ALFA



Primary Outcome Measures :
  1. Percentage of Participants by Family History of Factor VIII Inhibitor [ Time Frame: 4 years ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hemophilia A
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790828


Locations
Korea, Republic of
Yonsei Rehabilitation Clinic
Guro-gu, Seoul, Korea, Republic of, 152-834
Kim Hugh Chul Internal Medicine Clinic
Songpa-gu, Seoul, Korea, Republic of, 138-879
Pusan National University Hospital
Busan, Korea, Republic of, 632-739
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01790828     History of Changes
Other Study ID Numbers: B1831078
First Posted: February 13, 2013    Key Record Dates
Results First Posted: August 17, 2015
Last Update Posted: August 17, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants