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Trial record 3 of 3 for:    "Protein C deficiency"
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Ceprotin Treatment Registry

This study is currently recruiting participants.
Verified September 2012 by Baxter Healthcare Corporation
Sponsor:
Collaborators:
American Thrombosis and Hemostasis Network
UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01127529
First received: April 16, 2010
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Severe Congenital Protein C Deficiency
 Biological: Protein C Concentrate (Human)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ceprotin Treatment Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Medical diagnoses associated with Ceprotin treatment [ Time Frame: June 2015 ] [ Designated as safety issue: No ]
  • Ceprotin treatment regimens [ Time Frame: June 2015 ] [ Designated as safety issue: No ]
  • Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs) [ Time Frame: June 2015 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Ceprotin

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

Subjects 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 subject or the subject's legally authorized representative prior to enrollment, as applicable
  • Males and females of any age, including neonates, children, adolescents and adults
  • Subject who received CEPROTIN or is initiating/receiving CEPROTIN treatment

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127529

Contacts
Contact: Darby E Stephens, Clinical Project Manager darby_stephens@baxter.com

  Show 28 Study Locations
Sponsors and Collaborators
Baxter Healthcare Corporation
American Thrombosis and Hemostasis Network
UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)
Investigators
Study Director: Neil Inhaber, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01127529     History of Changes
Other Study ID Numbers: 400701
Study First Received: April 16, 2010
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Germany: Paul-Ehrlich-Institut
The Netherlands: Medicines Evaluation Board
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Protein C Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Thrombophilia
Genetic Diseases, Inborn
Protein C
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013