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:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161720
First received: September 8, 2005
Last updated: January 29, 2007
Last verified: October 2006
  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 Phase
Protein C Deficiency
Drug: Protein C Concentrate (Human) Vapor Heated
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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 Baxter Healthcare Corporation:

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Baxter Healthcare Corporation
Investigators
Principal Investigator: Taru Hays, MD Children´s Hospital, Denver, CO, USA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161720     History of Changes
Other Study ID Numbers: 400501
Study First Received: September 8, 2005
Last Updated: January 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:
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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014