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NCT04677101: LIBRA

Liquid Biopsy for NASH and Liver Fibrosis

Completed Last updated 19 May 2021
What this trial tests

trial testing Liver Biopsy in NASH - Nonalcoholic Steatohepatitis in 150 participants. Completed in 16 April 2021.

Timeline
16 December 2020
Primary endpoint
16 March 2021
16 April 2021

Quick facts

Lead sponsorCatholic University of the Sacred Heart
StatusCompleted
Study typeOBSERVATIONAL
Enrollment150
Start date16 December 2020
Primary completion16 March 2021
Estimated completion16 April 2021
Sites2 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Catholic University of the Sacred Heart

Who can join

Eligibility, any sex, with NASH - Nonalcoholic Steatohepatitis or Liver Fibroses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 etiology for hepatocellular carcinoma (HCC) in the United States. NAFLD is characterized by the excess accumulation of lipids within the liver and ranges from isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by the presence of hepatic necroinflammation, hepatocyte ballooning and fibrosis progression. Currently, liver biopsy remains the gold standard for the diagnosis of various chronic liver diseases, and for determining the severity of liver injury, inflammation, and fibrosis stage. However, this procedure is invasive, prone to complications such as bleeding and is associated with sampling variability and limited representation of the whole liver. Other limitations include, the difficulty to monitor liver injury progression over time and underestimation of disease severity. Despite intensive research, currently available non-invasive blood tests are not sufficiently sensitive or specific and are therefore of limited use. Blood biomarkers might provide significant advances in the diagnosis and monitoring of disease progression and regression in clinical settings. Recently, liquid biopsy has emerged as a potential, less invasive, alternative to liver biopsy. In fact, it addresses several unmet clinical needs, including sensitivity, specificity, the determination of prognoses, and the prediction of therapeutic responses.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Accurate liquid biopsy for the diagnosis of non-alcoholic steatohepatitis and liver fibrosis.
    Angelini G, Panunzi S, Castagneto-Gissey L, Pellicanò F, et al · · 2023 · cited 44× · PMID 35820779 · DOI 10.1136/gutjnl-2022-327498
  2. Upper gut heat shock proteins HSP70 and GRP78 promote insulin resistance, hyperglycemia, and non-alcoholic steatohepatitis.
    Angelini G, Castagneto-Gissey L, Salinari S, Bertuzzi A, et al · · 2022 · cited 16× · PMID 36513656 · DOI 10.1038/s41467-022-35310-5
  3. NAFLD and NAFLD Related HCC: Emerging Treatments and Clinical Trials.
    Khare T, Liu K, Chilambe LO, Khare S. · · 2025 · cited 12× · PMID 39796162 · DOI 10.3390/ijms26010306

Verify or expand the search:

Other trials of Liver Biopsy

Trials testing the same drug.

Other recruiting trials for NASH - Nonalcoholic Steatohepatitis

Currently open trials in the same condition.

Other Catholic University of the Sacred Heart trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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