Ceprotin Treatment Registry

NCT ID: NCT01127529

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-23

Study Completion Date

2015-06-22

Brief Summary

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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.

Detailed Description

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Conditions

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Protein C Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Protein C Concentrate (Human)

Intervention Type BIOLOGICAL

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

Interventions

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Protein C Concentrate (Human)

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Ceprotin

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)

UNKNOWN

Sponsor Role collaborator

American Thrombosis and Hemostasis Network

NETWORK

Sponsor Role collaborator

Baxalta now part of Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Phoenix, Arizona, United States

Site Status

Orange, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Indianapolis, Indiana, United States

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Boston, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Lebanon, New Hampshire, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

Site Status

Fort Worth, Texas, United States

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Houston, Texas, United States

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Innsbruck, , Austria

Site Status

Vienna, , Austria

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Bonn, , Germany

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Frankfurt, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Magdeburg, , Germany

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Magstadt, , Germany

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Milan, , Italy

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Palermo, , Italy

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Rome, , Italy

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Vicenza, , Italy

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Nijmegen, , Netherlands

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Bradford, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

Site Status

Countries

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United States Austria Germany Italy Netherlands United Kingdom

Related Links

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https://clinicaltrials.takeda.com/study-detail/5f6b5fc84db2bf003ab460cc

To obtain more information on the study, click here/on this link.

Other Identifiers

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400701

Identifier Type: -

Identifier Source: org_study_id

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