Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 3 of 3 for:    "Protein C deficiency"

Ceprotin Treatment Registry

This study is ongoing, but not recruiting participants.
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: June 25, 2013
Last verified: June 2013
  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:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Medical diagnoses associated with Ceprotin treatment [ Time Frame: 2 to 5 years, or until the Registry is terminated ] [ Designated as safety issue: No ]
  • Ceprotin treatment regimens [ Time Frame: 2 to 5 years, or until the Registry is terminated ] [ 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: 2 to 5 years, or until the Registry is terminated ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment outcomes categorized by medical diagnosis [ Time Frame: 2 to 5 years, or until the Registry is terminated ] [ Designated as safety issue: No ]
    Evidence of halting or reversal of coagulopathy or thrombosis, end-organ damage, limb sparing, Length of Hospital Stay (LOS), and mortality

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 43
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 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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127529

  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: Leman Yel, 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: June 25, 2013
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
Blood Coagulation Disorders, Inherited
Blood Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Thrombophilia
Protein C
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014