Ceprotin Treatment Registry

Protein C Deficiency Clinical Trial

Official title:

Ceprotin Treatment Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127529
• Other study ID #: 400701
• Status: Completed
• Start date: June 23, 2010
• Est. completion date: June 22, 2015

Study information

• Verified date: March 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Protein C Deficiency

Intervention

Biological:
• Protein C Concentrate (Human)
Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Baxalta now part of Shire	American Thrombosis and Hemostasis Network, UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

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

External Links

•   To obtain more information on the study, click here/on this link.