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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00157118 |
The purpose of his study is to show that Protein C Concentrate is a safe and effective treatment for subjects with congenital protein C deficiency.
Depending on the type of treatment required, patients are assigned to one of 3 study parts: Part 1 is for the treatment of acute episodes, Part 2 is for short-term prophylaxis, and Part 3 is for long-term prophylaxis in infants aged less than 6 months only.
Condition | Intervention | Phase |
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Protein C Deficiency |
Drug: Protein C Concentrate (Human) Vapor Heated |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Clinical Study for the Determination of the Efficacy and Safety of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Children´s Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Colorado | |
Children´s Hospital | |
Denver, Colorado, United States, 80218 | |
United States, Georgia | |
Emory University School of Medicine | |
Atlanta, Georgia, United States, 30322 | |
United States, Indiana | |
Indiana Hemophilia and Thrombosis Center | |
Indianapolis, Indiana, United States, 46260 | |
United States, Kentucky | |
University of Kentucky, Kentucky Clinic, Pediatric Hematology/Oncology | |
Lexington, Kentucky, United States, 40536 | |
United States, Massachusetts | |
Children´s Hospital Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, Ohio | |
University of Cincinnati, Hemophilia Treatment Center | |
Cincinnati, Ohio, United States, 45267 | |
Rainbow Babies & Children´s Hospital | |
Cleveland, Ohio, United States, 44106 | |
The Children´s Medical Center - Dayton | |
Dayton, Ohio, United States, 45404 | |
United States, Texas | |
Texas Children´s Hospital | |
Houston, Texas, United States, 77030 | |
University of Texas Medical Branch | |
Galveston, Texas, United States, 77555 | |
Cook Children´s Medical Center | |
Fort Worth, Texas, United States, 76104 |
Principal Investigator: | Taru Hays, MD | Children´s Hospital, Denver, CO, USA |
Study ID Numbers: | 400101 |
Study First Received: | September 8, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00157118 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Severe congenital protein C deficiency |
Fibrin Modulating Agents Anticoagulants Protein C Genetic Diseases, Inborn Blood Protein Disorders Hematologic Diseases |
Thrombophilia Blood Coagulation Disorders Protein C Deficiency Fibrinolytic Agents Cardiovascular Agents Hemostatic Disorders |
Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Thrombophilia Protein C Deficiency Hematologic Agents |
Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents Blood Coagulation Disorders, Inherited Genetic Diseases, Inborn Protein C Therapeutic Uses |