Post Marketing Surveillance Study for ADYNOVATE in South Korea

Takeda341 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

341

Conditions

Hemophilia A

Interventions

ADYNOVATEBIOLOGICAL

Pegylated recombinant human factor VIII

Eligibility

Medical Language ↔ Plain English

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.

Locations (8)

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Daegu Catholic University Medical Center

Daegu, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Kim Hugh Chul Internal Medicine

Seoul, South Korea

Korea Hemophilia Foundation (Seoul)

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

Outcomes

Primary Outcomes

Incidence of adverse events

Serious adverse events and non-serious adverse events

Time frame: Throughout the duration of patient participation of up to approximately 6 months

Frequency of adverse events

Serious adverse events and non-serious adverse events

Time frame: Throughout the duration of patient participation of up to approximately 6 months

Secondary Outcomes

Incidence of inhibitor titers for FVIII antibodies

By titer levels, high and lower titer categories

Time frame: Throughout the duration of patient participation of up to approximately 6 months

Number of treated bleeds

Number of treated bleeds throughout the study period

Time frame: Throughout the duration of patient participation of up to approximately 6 months

ADYNOVATE units required for bleed resolution

Number of ADYNOVATE units required for bleed resolution

Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months

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

Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months

Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment

Using a 4-point ordinal scale (Excellent, Good, Fair, or None)

Time frame: Throughout the duration of patient participation of up to approximately 6 months

Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen

Using a 4-point ordinal scale (Excellent, Good, Fair, or None)

Time frame: At bleed resolution, throughout the duration of patient participation of up to approximately 6 months

Assessment of perioperative effectiveness of ADYNOVATE

Using a 4-point ordinal scale (Excellent, Good, Fair, or None)

Time frame: Throughout the duration of patient participation of up to approximately 6 months

Clinically significant changes in laboratory results

Number of clinically significant changes in laboratory results

Time frame: Throughout the duration of patient participation of up to approximately 6 months