Ceprotin Treatment Registry
Completed
- Conditions
- Protein C Deficiency
- 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
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
- 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