Protein C Deficiency Clinical Trial
Official title:
Ceprotin Treatment Registry
NCT number | NCT01127529 |
Other study ID # | 400701 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 23, 2010 |
Est. completion date | June 22, 2015 |
Verified date | March 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | June 22, 2015 |
Est. primary completion date | June 22, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Baxalta now part of Shire | American Thrombosis and Hemostasis Network, UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG) |
United States, Austria, Germany, Italy, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medical diagnoses associated with Ceprotin treatment | 2 to 5 years, or until the Registry is terminated | ||
Primary | Ceprotin treatment regimens | 2 to 5 years, or until the Registry is terminated | ||
Primary | 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 | ||
Secondary | Treatment outcomes categorized by medical diagnosis | Evidence of halting or reversal of coagulopathy or thrombosis, end-organ damage, limb sparing, Length of Hospital Stay (LOS), and mortality | 2 to 5 years, or until the Registry is terminated | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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