Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Recruiting Phase 2 Interventional Study
NASH - Nonalcoholic Steatohepatitis
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
114 (estimated)
Sponsor
Can-Fite BioPharma · Industry
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About This Trial

Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age. 2. AST at Screening of ≥20 IU/L. 3. FibroScan LSM ≥8.5 kPa 4. Diagnosis of NASH by biopsy at Screening showing NAS ≥4 by central read, with a score of at least 1 point in each of the 3 histologic categories of steatosis, inflammation, and hepatocellu…
Contacts

Zivit Harpaz

+972-3-9241114

Zivit@canfite.co.il

CONTACT

Pnina Fishman, PhD

+972-3-9241114

pnina@canfite.co.il

CONTACT