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Post Marketing Surveillance Study for ADYNOVATE in South Korea

NCT03824522 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 341

Last updated 2024-02-26

No results posted yet for this study

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

Interventions

BIOLOGICAL

ADYNOVATE

Pegylated recombinant human factor VIII

Sponsors & Collaborators

  • Takeda Pharma Korea Co. Ltd.

    collaborator UNKNOWN

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2024-01-05
Completion
2024-01-05

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824522 on ClinicalTrials.gov