Ceprotin Treatment Registry

Baxalta

Status: Completed

Conditions: Protein C Deficiency

Treatments: Biological: Protein C Concentrate (Human)

Study type: Observational

Funder types: NETWORK; Industry; Other

Identifiers

NCT01127529

400701

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

43 participants in 1 patient group

Subjects with severe congenital protein C deficiency

Description:

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.

Treatment:

Biological: Protein C Concentrate (Human)