Clinical trial NCT03824522: Post Marketing Surveillance Study for ADYNOVATE in South Korea
Official title: Post Marketing Surveillance Study for ADYNOVATE in South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda Pharma Korea Co. Ltd.
First posted: 2019-01-31
Enrollment: 341
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemophilia A participants in South Korea who will be newly prescribed with ADYNOVATE or already been prescribed with ADYNOVATE will be included in this study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Throughout the duration of patient participation of up to approximately 6 months
measure: Frequency of adverse events
timeFrame: Throughout the duration of patient participation of up to approximately 6 months
Secondary outcomes:
measure: Incidence of inhibitor titers for FVIII antibodies
timeFrame: Throughout the duration of patient participation of up to approximately 6 months
measure: Number of treated bleeds
timeFrame: Throughout the duration of patient participation of up to approximately 6 months
measure: ADYNOVATE units required for bleed resolution
timeFrame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
measure: Number of ADYNOVATE infusions needed for the treatment of bleeding episodes
timeFrame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
measure: Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment
timeFrame: Throughout the duration of patient participation of up to approximately 6 months
measure: Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen
timeFrame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months
measure: Assessment of perioperative effectiveness of ADYNOVATE
timeFrame: Throughout the duration of patient participation of up to approximately 6 months
measure: Clinically significant changes in laboratory results
timeFrame: Throughout the duration of patient participation of up to approximately 6 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Kim Hugh Chul Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Korea Hemophilia Foundation (Seoul)
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: