Ceprotin Treatment Registry

Completed

• Conditions: Protein C Deficiency
• Interventions: Biological: Protein C Concentrate (Human)

• Registration Number: NCT01127529
• Lead Sponsor: Baxalta now part of Shire

Brief Summary

The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Study Start: 2010-06-23
• Primary Completion: 2015-06-22
• Study Completion: 2015-06-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study:

• Signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable
• Males and females of any age, including neonates, children, adolescents and adults
• Participant who received CEPROTIN or is initiating/receiving CEPROTIN treatment

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with severe congenital protein C deficiency	Protein C Concentrate (Human)	Registry subjects will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have subjects with severe congenital protein C deficiency, as well as by working with centers that use Ceprotin in emergency care situations.

Primary Outcome Measures

Name	Time	Method
Ceprotin treatment regimens	2 to 5 years, or until the Registry is terminated
Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs)	2 to 5 years, or until the Registry is terminated
Medical diagnoses associated with Ceprotin treatment	2 to 5 years, or until the Registry is terminated

Secondary Outcome Measures

Name	Time	Method
CEPROTIN use and treatment outcomes in pregnancy, labor and delivery, surgery and invasive procedures, different age groups, and, in the presence of pre-existing renal and/or hepatic dysfunction	2 to 5 years, or until the Registry is terminated
Treatment outcomes categorized by medical diagnosis	2 to 5 years, or until the Registry is terminated	Evidence of halting or reversal of coagulopathy or thrombosis, end-organ damage, limb sparing, Length of Hospital Stay (LOS), and mortality