Post Marketing Surveillance Study for ADYNOVATE in South Korea

NCT03824522 | Completed

• 1 other identifier: 261603
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 8

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.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Serious adverse events and non-serious adverse events

  Throughout the duration of patient participation of up to approximately 6 months

• 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 Outcomes (8)

• Incidence of inhibitor titers for FVIII antibodies

  Throughout the duration of patient participation of up to approximately 6 months

• Number of treated bleeds

  Throughout the duration of patient participation of up to approximately 6 months

• ADYNOVATE units required for bleed resolution

  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

  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

  Throughout the duration of patient participation of up to approximately 6 months

Study Arms (1)

All Study Participants

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.

Biological: ADYNOVATE

Interventions

ADYNOVATE BIOLOGICAL

Pegylated recombinant human factor VIII

Also known as: PEGylated rFVIII

All Study Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead
• Takeda Pharma Korea Co. Ltd.: collaborator

Study Sites (8)

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Kim Hugh Chul Internal Medicine

Seoul, 05538, South Korea

Location

Korea Hemophilia Foundation (Seoul)

Seoul, 06641, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Related Links

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

MeSH Terms

Conditions

Hemophilia A

Interventions

BAX 855

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: February 25, 2019
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

KR (8)