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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01790828
First received: February 11, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Hemophilia A
Drug: Xyntha : coagulation factor IIIV (recombinant)
Phase 4

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The clinical nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; outcome and possible causality will be monitored at every visit in this study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy endpoint: annualized bleeding rates (ABRs) and responses to the on-demand treatment with BeneFIX for all bleeds (4-point scale of assessment: excellent, good, moderate, no response) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2014
Estimated Study Completion Date: August 2014
Estimated 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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Korea, Republic of
Yonsei Rehabilitation Clinic Not yet recruiting
Guro-gu, Seoul, Korea, Republic of, 152-834
Pusan National Univ. Hospital Recruiting
Busan, Korea, Republic of, 602-739
Konyang University Hospital Not yet recruiting
Daejeon, Korea, Republic of, 302-718
Kyung Hee University Hospital at Gangdong Recruiting
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
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014