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Sponsors and Collaborators: |
Children's Hospital Los Angeles National Institutes of Health (NIH) |
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Information provided by: | Children's Hospital Los Angeles |
ClinicalTrials.gov Identifier: | NCT00812370 |
Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are available but have not been systematically tested in children. This study will determine whether one such medication, bivalirudin is a safer and more effective alterative.
This study will monitor what effects the drug has upon the child's body and how the body processes the study drug (absorption, metabolism and elimination). The study will also evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The safety issues being monitored relate to any observations of major or minor bleeding episodes after taking the drug, and/or any other side effects.
Condition | Intervention | Phase |
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Deep Venous Thrombosis |
Drug: Bivalirudin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Dose-Finding, Pharmacokinetic, Safety and Efficacy Study of Bivalirudin in Children Between 6 Months and 18 Years of Age |
Estimated Enrollment: | 30 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
This will be an open-label, single-arm, dose-finding, pharmacokinetic, safety and efficacy study of bivalirudin in children 6 months to 18 years of age with deep vein thrombosis. The specific aims are as follows:
A total of 30 patients will be enrolled in this study. They will be divided into 3 groups according to their age range (6 months-age to > 5, 5 to > 12 years and 12 to >18 years). The patient must have a deep vein thrombosis (clot in an artery or vein) that has been seen on an imaging test. After receiving the study drug, the subjects will then have blood tests at specific timepoints to measure how the drug is effecting the body and how the drug is acting once it is in the body. Based upon the levels of the blood tests, the dose of the study drug may be adjusted or stopped. The subject will continue on the drug until the clot is dissolved, the subject is prescribed a different anticoagulant or the physician or parents decide to remove the child off of the study. The drug will also be discontinued if any excessive bleeding or severe side effects related to the drug are observed. A follow up imaging study will be performed on all patients 48-72 hours after the drug was started. If the clot is still present at this time, another imaging study will be done at 30 days after the drug was given. The subjects will continue to have lab tests twice weekly for about 3 weeks to monitor for the effects of the drug. After completion of the study, the patient will undergo a study exit physical exam between 20-40 days after the drug was stopped.
Ages Eligible for Study: | 6 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Harrington, RN | 323-361-7319 | jeharrington@chla.usc.edu |
Contact: Rachna Khanna, BS | 323-361-2207 | rkhanna@chla.usc.edu |
United States, California | |
Childrens Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Jennifer Harrington, BSN 323-361-7319 jeharrington@chla.usc.edu | |
Contact: Rachna Khanna, BS 323.361.2206 rkhanna@chla.usc.edu | |
Principal Investigator: Guy Young, MD | |
United States, Colorado | |
UCD Hemophilia & Thrombosis Center | Not yet recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Meghan J Calhoon 303-724-1327 meghan.calhoon@ucdenver.edu | |
Principal Investigator: Marilyn Manco-Johnson, MD | |
Principal Investigator: Neil Goldenberg, MD | |
United States, Illinois | |
Comprehensive Bleeding Disorder Center | Not yet recruiting |
Peoria, Illinois, United States, 61614 | |
Contact: Michiyo Tomita, MD 309-688-1345 mtomita@hemophilia-ctr-peoria.com | |
Principal Investigator: Michael Tarantino, MD | |
United States, Ohio | |
Nationwide Children's Hospital | Recruiting |
Columbus, Ohio, United States, 432005 | |
Contact: Kami Perdue 614-722-6885 kami.perdue@nationwidechildrens.org | |
Principal Investigator: Sarah O'Brien, MD | |
United States, Pennsylvania | |
The Childrens Hospital of Philidelphia | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Joseph Banta 267-426-7096 bantaj@email.chop.edu | |
Principal Investigator: Leslie Raffini, MD | |
United States, Texas | |
Baylor College of Medicine/Texas Children's Hospital | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: Sarah J McVey, BSN, RN 832-824-4216 sjmcvey@txccc.org | |
Principal Investigator: Donald Yee, MD | |
University of Texas Southwestern Medical Center at Dallas | Not yet recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Roberto Torres, MA 214-456-6095 Roberto.torres@childrens.com | |
Principal Investigator: Janna Journeycake, MD |
Principal Investigator: | Guy A Young, MD | CHLA |
Responsible Party: | CHLA ( Guy Young, MD ) |
Study ID Numbers: | 3070850 |
Study First Received: | December 18, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00812370 |
Health Authority: | United States: Food and Drug Administration |
DVT Deep Venous Thrombosis UNBLOCK Bivalirudin Angiomax |
Signs and Symptoms Embolism and Thrombosis Embolism Bivalirudin |
Vascular Diseases Venous Thrombosis Thrombosis |
Anticoagulants Therapeutic Uses Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |