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Ceprotin Treatment Registry

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Congenital Protein C Deficiency

Intervention: Protein C Concentrate (Human) (Biological)

Phase: N/A

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Mahmoud Loghman-Adham, MD, Study Director, Affiliation: Baxter Healthcare Corporation

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.

Clinical Details

Official title: Ceprotin Treatment Registry

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Medical diagnoses associated with Ceprotin treatment

Ceprotin treatment regimens

Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs)

Secondary outcome:

Treatment outcomes categorized by medical diagnosis

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

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Innsbruck, Austria

Vienna, Austria

Bonn, Germany

Frankfurt, Germany

Hannover, Germany

Heidelberg, Germany

Magdeburg, Germany

Magstadt, Germany

Milan, Italy

Palermo, Italy

Rome, Italy

Vicenza, Italy

Nijmegen, Netherlands

Bradford, United Kingdom

London, United Kingdom

Manchester, United Kingdom

Phoenix, Arizona, United States

Orange, California, United States

Aurora, Colorado, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

Grand Rapids, Michigan, United States

Lebanon, New Hampshire, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Ft. Worth, Texas, United States

Houston, Texas, United States

Additional Information

Starting date: June 2010
Last updated: July 10, 2015

Page last updated: August 20, 2015

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