A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency
Sponsored by Takeda
About this trial
Last updated 7 months ago
Study ID
TAK-662-4002
Status
Recruiting
Type
Observational
Placebo
No
Accepting
All
All
Not accepting
Healthy Volunteers
Trial Timing
Started 2 years ago
What is this trial about?
This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662)
used to treat participants with congenital protein C deficiency.
The main aim of the study is to evaluate for adverse events and effectiveness of
congenital protein C deficiency (TAK-662).
During the study, participants with congenital protein C deficiency will be administered
with TAK-662 intravenous injection in under routine normal practice. The investigators
will evaluate adverse events due to TAK-662 for 12 months. For participants who will be
administered in long-term supplementation of TAK-662 after acute treatment or short-term
supplementation, the investigator will evaluate for 24 months as a maximum. The study
sponsor will not be involved in how the participants are administered but will be
recorded what happens during the study.
What are the participation requirements?
Inclusion Criteria
All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662) in Japan.