Post Marketing Surveillance Study for ADYNOVATE in South Korea

Completed

• Conditions: Hemophilia A
• Interventions: Biological: ADYNOVATE

• Registration Number: NCT03824522
• Lead Sponsor: Takeda

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Study Start: 2019-02-25
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Study Participants	ADYNOVATE	Participants who are newly prescribed with Adynovate and participants previously treated with Adynovate will be treated with ADYNOVATE for hemophilia A at the time of enrollment according to a regimen determined by the study site treating physician.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Throughout the duration of patient participation of up to approximately 6 months	Serious adverse events and non-serious adverse events
Frequency of adverse events	Throughout the duration of patient participation of up to approximately 6 months	Serious adverse events and non-serious adverse events

Secondary Outcome Measures

Name	Time	Method
Number of treated bleeds	Throughout the duration of patient participation of up to approximately 6 months	Number of treated bleeds throughout the study period
ADYNOVATE units required for bleed resolution	At bleed resolution, throughout the duration of patient participation of up to approximately 6 months	Number of ADYNOVATE units required for bleed resolution
Clinically significant changes in laboratory results	Throughout the duration of patient participation of up to approximately 6 months	Number of clinically significant changes in laboratory results
Incidence of inhibitor titers for FVIII antibodies	Throughout the duration of patient participation of up to approximately 6 months	By titer levels, high and lower titer categories
Assessment of perioperative effectiveness of ADYNOVATE	Throughout the duration of patient participation of up to approximately 6 months	Using a 4-point ordinal scale (Excellent, Good, Fair, or None)
Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment	Throughout the duration of patient participation of up to approximately 6 months	Using a 4-point ordinal scale (Excellent, Good, Fair, or None)
Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen	At bleed resolution, throughout the duration of patient participation of up to approximately 6 months	Using a 4-point ordinal scale (Excellent, Good, Fair, or None)
Number of ADYNOVATE infusions needed for the treatment of bleeding episodes	At bleed resolution, throughout the duration of patient participation of up to approximately 6 months	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

Trial Locations

Locations (8)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Kyungpook National University Chilgok Hospital; 🇰🇷 Daegu, Korea, Republic of

Korea Hemophilia Foundation (Seoul); 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Severance Hospital Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Kim Hugh Chul Internal Medicine; 🇰🇷 Seoul, Korea, Republic of