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

Hemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790828
• Other study ID #: B1831078
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: July 21, 2015
• Start date: February 2014
• Est. completion date: August 2014

Study information

• Verified date: July 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

non probability sample

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• Xyntha : coagulation factor IIIV (recombinant)
Xyntha will be administered according to physician's discretion.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Yonsei Rehabilitation Clinic	Guro-gu	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Kim Hugh Chul Internal Medicine Clinic	Songpa-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants by Family History of Factor VIII Inhibitor		4 years	No
Secondary	Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)		4 years	No
Secondary	Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age		4 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)		4 years	No
Secondary	Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age		4 years	No
Secondary	Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants =18 Years of Age		4 years	No
Secondary	Percentage of Participants Experiencing Hemorrhages During Prophylaxis		4 years	No
Secondary	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	No
Secondary	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	No
Secondary	Average Infusion Dose During Prophylaxis (All Participants)		4 years	No
Secondary	Average Infusion Dose During Prophylaxis in Participants <18 Years of Age		4 years	No
Secondary	Average Infusion Dose During Prophylaxis in Participants =18 Years of Age		4 years	No
Secondary	Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)		4 years	No
Secondary	Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age		4 years	No
Secondary	Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants =18 Years of Age		4 years	No

External Links

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