Clinical trial NCT01127529: Ceprotin Treatment Registry
Official title: Ceprotin Treatment Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Protein C Deficiency
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)
name: American Thrombosis and Hemostasis Network
First posted: 2010-05-21
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Medical diagnoses associated with Ceprotin treatment
timeFrame: 2 to 5 years, or until the Registry is terminated
measure: Ceprotin treatment regimens
timeFrame: 2 to 5 years, or until the Registry is terminated
measure: Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs)
timeFrame: 2 to 5 years, or until the Registry is terminated
Secondary outcomes:
measure: Treatment outcomes categorized by medical diagnosis
timeFrame: 2 to 5 years, or until the Registry is terminated
measure: 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
timeFrame: 2 to 5 years, or until the Registry is terminated
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Orange
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Indianapolis
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Lebanon
country: United States
state: New Hampshire
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Innsbruck
country: Austria
city: Vienna
country: Austria
city: Bonn
country: Germany
city: Frankfurt
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Magdeburg
country: Germany
city: Magstadt
country: Germany
city: Milan
country: Italy
city: Palermo
country: Italy
city: Rome
country: Italy
city: Vicenza
country: Italy
city: Nijmegen
country: Netherlands
city: Bradford
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: