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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01790828
First received: February 11, 2013
Last updated: July 21, 2015
Last verified: July 2015
  Purpose

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


Condition Intervention
Hemophilia A
Drug: Xyntha : coagulation factor IIIV (recombinant)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha 'Registered' In Subjects With Hemophilia A

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants by Family History of Factor VIII Inhibitor [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Response categories were excellent, good, moderate, or no response.

  • 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 ] [ Designated as safety issue: No ]
    Response categories were excellent, good, moderate, or no response.

  • 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 ] [ Designated as safety issue: No ]
    Response categories were excellent, good, moderate, and no response.

  • Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.

  • Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Percentage of Participants Experiencing Hemorrhages During Prophylaxis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Annualized Bleeding Rates During Prophylaxis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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)]

  • Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.

  • Average Infusion Dose During Prophylaxis (All Participants) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Average Infusion Dose During Prophylaxis in Participants <18 Years of Age [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: February 2014
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

non probability sample

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01790828     History of Changes
Other Study ID Numbers: B1831078
Study First Received: February 11, 2013
Results First Received: July 21, 2015
Last Updated: July 21, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Factor VIII
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015