NCT01629095|Terminated
Study Stopped
Slow/insufficient accrual
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Slow/insufficient accrual
Sponsor study identifier
Secondary identifiers
observational
17
1 country
5
Study Start
April 23, 2013
Actual (reported)Primary Completion
January 9, 2017
Actual (reported)Study Completion
January 9, 2017
Actual (reported)Background: \- Non-alcoholic fatty liver disease is the most common form of liver disease in the United States. It includes many conditions. Researchers want to study fatty liver disease by looking at people who have liver cirrhosis. They also want to look at people who are or were listed for liver transplants. Genetic studies may provide more information on the causes of these conditions. Objectives: \- To study possible genetic causes of non-alcoholic fatty liver disease. Eligibility: \- Individuals of any age who have non-alcoholic fatty liver disease and related conditions. Design:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 9, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 22, 2012
Actual (reported)June 27, 2012
Actual (reported)April 23, 2013
Actual (reported)January 9, 2017
Actual (reported)January 9, 2017
Actual (reported)To better understand the underlying mechanisms of liver regeneration and the development of NASH.
(a) To determine the role of the Sonic Hedgehog signaling pathway and related genes in the predisposition to liver injury and NASH.(b) To compare gene variants (with known or suspected abnormal functional effects) with the phenotypes observed in patients (i.e. genotype- phenotype correlations) as documented in the study.(c) To verify recurrence risks /inheritance patterns for each of the candidate genes.
One point in time
Patients who have already undergone liver transplantation for a confirmed diagnosis of NAFLD or cryptogenic cirrhosis are also eligible to participate.
Patients with radiologic evidence of fatty liver and/or cirrhosis in which other causes havebeen ruled out are eligible to participate.
Although a liver biopsy is necessary to make the diagnosis of NASH, patients with radiologic evidence of fatty liver and/or cirrhosis in which other causes have been ruled out are eligible to participate. Patients who have already undergone liver transplantation for a confirmed diagnosis of NAFLD orcryptogenic cirrhosis are also eligible to participate.Direct blood relatives (typically parents and siblings) of affected individuals with NAFLD and associated conditions are also eligible to participate.
University of California, San Francisco
San Francisco, California, 94143, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7030, United States
Cleveland Clinic Transplantation Clinic
Cleveland, Ohio, United States
Baylor University Medical Center
Dallas, Texas, United States
Paul S Kruszka, M.D.
National Human Genome Research Institute (NHGRI)
17 participants (actual enrollment reported by the registry).
First Submitted
June 22, 2012
First Posted
June 27, 2012
Study Start
April 23, 2013
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 9, 2017
Actual (reported)Study Completion
January 9, 2017
Actual (reported)Last Updated
November 27, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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