Ceprotin Treatment Registry

NCT01127529 — Completed, 43 participants, Baxalta now part of Shire

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RegistryNCT01127529
StatusCompleted
Study typeObservational
Enrollment43 (Actual)
SponsorBaxalta now part of Shire (Industry); collaborators: UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG), American Thrombosis and Hemostasis Network
ConditionsProtein C Deficiency
InterventionsProtein C Concentrate (Human) (Biological)
Datesstart 2010-06-23, primary completion 2015-06-22, completion 2015-06-22, first posted 2010-05-21, last updated 2021-03-17
Locations28 sites in United States, Austria, Germany, Italy, Netherlands, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Protein C Deficiency All trials of Protein C Concentrate (Human)

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Subjects with severe congenital protein C deficiencyBiological: Protein C Concentrate (Human)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.
  • Protein C Concentrate (Human) (Biological), also known as Ceprotin: Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care.

+Outcome measures

Primary outcomes

  • Medical diagnoses associated with Ceprotin treatment [2 to 5 years, or until the Registry is terminated]
  • Ceprotin treatment regimens [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) [2 to 5 years, or until the Registry is terminated]

Secondary outcomes

  • Treatment outcomes categorized by medical diagnosis [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
  • 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 [2 to 5 years, or until the Registry is terminated]

+Eligibility

Sex: All

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

+Locations (28)

FacilityCityCountryStatus
Phoenix, ArizonaUnited States
Orange, CaliforniaUnited States
Aurora, ColoradoUnited States
Indianapolis, IndianaUnited States
Boston, MassachusettsUnited States
Grand Rapids, MichiganUnited States
Lebanon, New HampshireUnited States
Cincinnati, OhioUnited States
Columbus, OhioUnited States
Dayton, OhioUnited States
Fort Worth, TexasUnited States
Houston, TexasUnited States
InnsbruckAustria
ViennaAustria
BonnGermany
FrankfurtGermany
HanoverGermany
HeidelbergGermany
MagdeburgGermany
MagstadtGermany
MilanItaly
PalermoItaly
RomeItaly
VicenzaItaly
NijmegenNetherlands
BradfordUnited Kingdom
LondonUnited Kingdom
ManchesterUnited Kingdom

+Investigators

  • Study Director, Study director, Takeda