For Healthcare Professionals

Post Marketing Surveillance Study for ADYNOVATE in South Korea

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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:

  1. The participant or legally authorized representative has given written informed consent to participate in the study.
  2. The participant is indicated for treatment according to the ADYNOVATE South Korea prescribing information (PI).

EXCLUSION CRITERIA

Exclusion Criteria

Participants should be excluded from this study if:

  1. The participant or legally authorized representative does not wish to participate in the study.
  2. Any of the contraindications included in the PI for ADYNOVATE apply.
  3. Participant is enrolled in an interventional trial using an investigational product other than ADYNOVATE.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1-877-825-3327Email iconEmail Study Center

Study’s details


Contition

Hemophilia A

Participants needed

600

Est. Completion Date

Jan 30, 2024

Treatment type

Observational


Sponsor

Takeda

ClinicalTrials.gov identifier

NCT03824522

Study number

261603

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.