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

NCT04697810 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-07-31

No results posted yet for this study

Summary

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.

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

Namodenoson

25 mg q12hours x 36 weeks

DRUG

Placebo

Matching capsules q12hours x 36 weeks

Sponsors & Collaborators

  • Can-Fite BioPharma

    lead INDUSTRY

Principal Investigators

  • Michael H Silverman, MD · BioStrategics Consulting Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2025-04-15
Completion
2025-10-15

Countries

  • Bosnia and Herzegovina
  • Bulgaria
  • Israel
  • Moldova
  • Romania
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697810 on ClinicalTrials.gov