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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

18-75 Years
All
All
All

Not accepting

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?

Yes

Inclusion Criteria

All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662) in Japan.

Locations

Location

Status

Recruiting

For more information, view the full study details:

NCT06590974jRCT2031240322