Ceprotin Treatment Registry

March 15, 2021 updated by: Baxalta now part of Shire
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
      • Vienna, Austria
  • Germany
      • Bonn, Germany
      • Frankfurt, Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Magdeburg, Germany
      • Magstadt, Germany
  • Italy
      • Milan, Italy
      • Palermo, Italy
      • Rome, Italy
      • Vicenza, Italy
  • Netherlands
      • Nijmegen, Netherlands
  • United Kingdom
      • Bradford, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Orange, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Grand Rapids, Michigan, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
    • Texas
      • Fort Worth, Texas, United States
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Registry participants will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have participants with severe congenital Protein C deficiency, as well as by working with centers that use CEPROTIN in emergency care situations.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with severe congenital protein C deficiency
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.
Biological: Protein C Concentrate (Human)
Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care.
Other Names:
  • Ceprotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medical diagnoses associated with Ceprotin treatment
Time Frame: 2 to 5 years, or until the Registry is terminated
2 to 5 years, or until the Registry is terminated
Ceprotin treatment regimens
Time Frame: 2 to 5 years, or until the Registry is terminated
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)
Time Frame: 2 to 5 years, or until the Registry is terminated
2 to 5 years, or until the Registry is terminated

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment outcomes categorized by medical diagnosis
Time Frame: 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
2 to 5 years, or until the Registry is terminated
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
Time Frame: 2 to 5 years, or until the Registry is terminated
2 to 5 years, or until the Registry is terminated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Collaborators

American Thrombosis and Hemostasis Network
UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2010

Primary Completion (Actual)

June 22, 2015

Study Completion (Actual)

June 22, 2015

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 400701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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