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

Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU (All-Case Surveillance)

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.

Study Overview

• Status: Recruiting
• Conditions: Protein C Deficiency
• Intervention / Treatment: Drug: Freeze-dried Human Protein C Concentrate

• Study Type: Observational
• Enrollment (Estimated): 7

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Japan
  • Tokyo
    • Tokyo, Tokyo, Japan
      • Recruiting
      • Takeda Selected Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population of this study are all participants who meet the inclusion/exclusion criteria.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Freeze-dried Human Protein C Concentrate (TAK-662); Participants will be administered Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection.	Drug: Freeze-dried Human Protein C Concentrate; Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants who Experience at Least One TEAE of Venous Thromboembolism	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)
Number of Participants who Experience at Least One TEAE of Purpura Fulminans	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)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Ceprotin/Protein C Deficiency
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Blood Protein Disorders; Blood Coagulation Disorders, Inherited; Thrombophilia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Protein C Deficiency; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Protein C
• Other Study ID Numbers: TAK-662-4002; jRCT2031240322 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No