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Sponsored by: |
University of Western Ontario, Canada |
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Information provided by: | University of Western Ontario, Canada |
ClinicalTrials.gov Identifier: | NCT00641524 |
The purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment for patients with non-alcoholic fatty liver disease.
Condition | Intervention |
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Non-Alcoholic Fatty Liver Disease |
Procedure: Phlebotomy |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of Phlebotomy as a Treatment for Non-Alcoholic Fatty Liver Disease |
Estimated Enrollment: | 36 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
In this study phlebotomy will be evaluated as a therapy for non-alcoholic fatty liver disease (NAFLD), a common and important cause of liver disease.
Phlebotomy has been used for many years in the treatment of disorders of iron overload such as hemochromatosis, where it is well tolerated and improves symptoms and survival. There is some evidence that it is also effective in treating NAFLD. However, previous studies have not evaluated whether phlebotomy improves liver biopsy findings. We will measure the severity disease in NAFLD patients prior to phlebotomy therapy and again at the end of treatment. This will allow us to accurately determine the benefit of this therapy in these patients.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Melanie D Beaton, MD | 519-663-3344 | Melanie.Beaton@lhsc.on.ca |
Contact: Paul C Adams, MD | 519-663-5375 | padams@uwo.on.ca |
Canada, Ontario | |
London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 5A5 | |
Contact: Melanie D Beaton, MD 519-663-3344 melanie.beaton@lhsc.on.ca | |
Contact: cathy wild 519-663-3344 cathy.wild@lhsc.on.ca | |
Principal Investigator: Melanie D Beaton, MD | |
Sub-Investigator: Paul C Adams, MD | |
Sub-Investigator: Paul Marotta, MD | |
Sub-Investigator: Mark Levstik, MD |
Principal Investigator: | Melanie D Beaton, MD | University of Western Ontario, Canada |
Responsible Party: | University of Western Ontario ( Dr. Melanie D Beaton, MD, FRCPC Assisstant Professor, Department of Medicine ) |
Study ID Numbers: | beatonclf |
Study First Received: | March 17, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00641524 History of Changes |
Health Authority: | Canada: Health Canada |
Non-alcoholic fatty liver disease liver fibrosis metabolic syndrome iron overload phlebotomy |
Liver Diseases Non-alcoholic Steatohepatitis (NASH) Digestive System Diseases Hepatic Fibrosis |
Fibrosis Fatty Liver Iron Overload Iron |
Liver Diseases Digestive System Diseases Fatty Liver |