A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency

Condition(s) studied

Investigational drug(s) / intervention(s)

Freeze-dried Human Protein C Concentrate: Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) — Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)

Trial sites (1)

More Takeda trials in Japan