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Sponsored by: |
Norgine |
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Information provided by: | Norgine |
ClinicalTrials.gov Identifier: | NCT00794716 |
This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard laboratory tests, elastography, tests of metabolic markers and serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD patients. Patients will be included if they have clinical evidence of fatty liver disease and have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood tests and scans of the liver.
Condition | Intervention | Phase |
---|---|---|
Non-Alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis |
Other: NRL972 |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective Single-Centre, Open-Label Study to Assess the Pharmacokinetics of Cholyl-Lysl-Fluorescein (NRL972) in Patients With Clinical Evidence for Non-Alcoholic Fatty Liver Disease (NAFLD): Supporting the Disease Staging Into Fatty Liver Disease Versus Non-Alcoholic Steatophepatitis (NASH) |
Estimated Enrollment: | 110 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects meeting the following conditions will be eligible for enrollment:
Exclusion Criteria:
Subjects fulfilling any of the following criteria will be excluded from enrollment:
General - all subjects
General - all females
Contact: Grainne O'Neill, BSc | +44 (0) 1895 453688 | goneill@norgine.com |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Manal F Abdelmalek, MD 919-684-8356 |
Principal Investigator: | Manal F Abdelmalek, M.D., MPH | Duke University |
Responsible Party: | Norgine Ltd ( Vice President, Clinical Development ) |
Study ID Numbers: | NRL972-01/2007 (FLD) |
Study First Received: | November 19, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00794716 |
Health Authority: | United States: Food and Drug Administration |
Liver Diseases Non-alcoholic steatohepatitis (NASH) Digestive System Diseases Fatty Liver |