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Trial record 3 of 3 for:    "Protein C deficiency"

Ceprotin Treatment Registry

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ClinicalTrials.gov Identifier: NCT01127529
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)
American Thrombosis and Hemostasis Network
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief 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.

Condition or disease Intervention/treatment
Protein C Deficiency Biological: Protein C Concentrate (Human)

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ceprotin Treatment Registry
Actual Study Start Date : June 23, 2010
Actual Primary Completion Date : June 22, 2015
Actual Study Completion Date : June 22, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Ceprotin



Primary Outcome Measures :
  1. Medical diagnoses associated with Ceprotin treatment [ Time Frame: 2 to 5 years, or until the Registry is terminated ]
  2. Ceprotin treatment regimens [ Time Frame: 2 to 5 years, or until the Registry is terminated ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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. 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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127529


  Show 28 Study Locations
Sponsors and Collaborators
Baxalta now part of Shire
UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)
American Thrombosis and Hemostasis Network
Investigators
Study Director: Mahmoud Loghman-Adham, MD Baxter Healthcare Corporation

Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01127529     History of Changes
Other Study ID Numbers: 400701
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

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
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action