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OpenTrials
Completed

NCT Number: NCT01127529

Ceprotin Treatment Registry

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.

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Key information

Conditions

Protein C Deficiency Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Thrombophilia

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein C Concentrate (Human)

Biological

Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care.

Other names: Ceprotin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Collaborators

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

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 21, 2010
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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