Status:
COMPLETED
Liquid Biopsy for NASH and Liver Fibrosis
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
NASH - Nonalcoholic Steatohepatitis
Liver Fibroses
Eligibility:
All Genders
Brief Summary
Nonalcoholic fatty liver disease (NAFLD) has evolved to represent the most common cause of chronic liver disease globally. Today, NAFLD is a leading indication for liver transplantation and a major et...
Detailed Description
This is a multicentric prospective observational study to validate blood non-invasive biomarkers for NASH and fibrosis stage. 150 subjects will be enrolled; 100 subjects with biopsy-proven NASH and 5...
Eligibility Criteria
Inclusion
- One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI ≥30 and ≤55 kg/m2.
- Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.
Exclusion
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; Liver cirrhosis; End stage renal failure; Participation in any other concurrent therapeutic clinical trial; Any other life-threatening, non-cardiac disease; Pregnancy; Inability to give informed consent; Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men); Wilson's disease; Lipodystrophy; Parenteral nutrition; Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids).
Key Trial Info
Start Date :
December 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04677101
Start Date
December 16 2020
End Date
April 16 2021
Last Update
May 19 2021
Active Locations (2)
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1
University of Rome Sapienza
Roma, Italy
2
Catholic University School of Medicine
Rome, Italy, 00168