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Trial record 2 of 3 for:    "Protein C deficiency"

Retrospective Study to Capture Dosing and Treatment Outcome Data in Subjects With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00161720
First Posted: September 13, 2005
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shire
  Purpose
This is a data collection study with the purpose of capturing dosing and treatment outcome data in subjects with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).

Condition Intervention
Protein C Deficiency Drug: Protein C Concentrate (Human) Vapor Heated

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Study to Capture Dosing and Treatment Outcome Data in Subjects With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND

Resource links provided by NLM:


Further study details as provided by Shire:

Study Start Date: June 2005
Estimated Study Completion Date: December 2005
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject treated with protein C concentrate under a Baxter Healthcare Corporation Emergency Use IND
  • Subject with diagnosis of severe congenital protein C deficiency
  • Subject or parent/legally authorized representative has provided written informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161720


Locations
United States, California
Children´s Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
Children´s Hospital Denver
Denver, Colorado, United States, 80218
Evans Army Hospital
Fort Carson, Colorado, United States, 80973
United States, Massachusetts
Children´s Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Ohio
Rainbow Babies & Children´s Hospital
Cleveland, Ohio, United States, 44106
The Children´s Medical Center - Dayton
Dayton, Ohio, United States, 45404
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Cook Children´s Medical Center
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Texas Children´s Hospital
Houston, Texas, United States, 80218
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
Principal Investigator: Taru Hays, MD Children´s Hospital, Denver, CO, USA
  More Information

ClinicalTrials.gov Identifier: NCT00161720     History of Changes
Other Study ID Numbers: 400501
First Submitted: September 8, 2005
First Posted: September 13, 2005
Last Update Posted: October 23, 2017
Last Verified: October 2006

Keywords provided by Shire:
Severe Congenital Protein C Deficiency

Additional relevant MeSH terms:
Protein C Deficiency
Emergencies
Disease Attributes
Pathologic Processes
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Thrombophilia
Genetic Diseases, Inborn
Protein C
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action