Post Marketing Surveillance Study for ADYNOVATE in South Korea

Hemophilia A Clinical Trial

Official title:

Post Marketing Surveillance Study for ADYNOVATE in South Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824522
• Other study ID #: 261603
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: January 5, 2024

Study information

• Verified date: February 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice. Also, it will be checked how effective ADYNOVATE is at stopping a bleed, at preventing bleeding episodes when used routinely for prevention and at controlling hemophilia-related bleeding during surgeries.

Participants with hemophilia A who will be newly prescribed with ADYNOVATE treatment or have already been taking ADYNOVATE treatment according to the physician's decision will be included in this study.

Participants will visit the study clinic as a part of their routine clinical practice and will be contacted by phone calls/home visits by home care workers for collection of treatment related data during the 6-month observation period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria

Participants with a diagnosis of hemophilia A who will be newly prescribed with ADYNOVATE or already have been prescribed ADYNOVATE according to the study physician's judgment shall be included in this study if:

• The participant or legally authorized representative has given written informed consent to participate in the study.

• The participant is indicated for treatment according to the ADYNOVATE South Korea prescribing information (PI).

Exclusion Criteria

Participants should be excluded from this study if:

• The participant or legally authorized representative does not wish to participate in the study.

• Any of the contraindications included in the PI for ADYNOVATE apply.

• Participant is enrolled in an interventional trial using an investigational product other than ADYNOVATE.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Biological:
• ADYNOVATE
Pegylated recombinant human factor VIII

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Kim Hugh Chul Internal Medicine	Seoul
Korea, Republic of	Korea Hemophilia Foundation (Seoul)	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Takeda Pharma Korea Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Serious adverse events and non-serious adverse events	Throughout the duration of patient participation of up to approximately 6 months
Primary	Frequency of adverse events	Serious adverse events and non-serious adverse events	Throughout the duration of patient participation of up to approximately 6 months
Secondary	Incidence of inhibitor titers for FVIII antibodies	By titer levels, high and lower titer categories	Throughout the duration of patient participation of up to approximately 6 months
Secondary	Number of treated bleeds	Number of treated bleeds throughout the study period	Throughout the duration of patient participation of up to approximately 6 months
Secondary	ADYNOVATE units required for bleed resolution	Number of ADYNOVATE units required for bleed resolution	At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
Secondary	Number of ADYNOVATE infusions needed for the treatment of bleeding episodes	The number of ADYNOVATE infusions needed for each bleeding episode is determined by the participant, his/her caregiver, and/or clinician treating the participant, and is based upon the participant's response to treatment	At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
Secondary	Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment	Using a 4-point ordinal scale (Excellent, Good, Fair, or None)	Throughout the duration of patient participation of up to approximately 6 months
Secondary	Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen	Using a 4-point ordinal scale (Excellent, Good, Fair, or None)	At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
Secondary	Assessment of perioperative effectiveness of ADYNOVATE	Using a 4-point ordinal scale (Excellent, Good, Fair, or None)	Throughout the duration of patient participation of up to approximately 6 months
Secondary	Clinically significant changes in laboratory results	Number of clinically significant changes in laboratory results	Throughout the duration of patient participation of up to approximately 6 months

External Links

•   To obtain more information on the study, click here/on this link