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An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis

NCT03656068 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-06-30

Study results available
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Summary

To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis

Conditions

  • Non-alcoholic Steatohepatitis
  • Fatty Liver
  • Fibrosis, Liver
  • Compensated Cirrhosis

Interventions

DRUG

Nitazoxanide 500mg BID

Patients will receive 500mg of Nitazoxanide BID daily for 24 weeks

Sponsors & Collaborators

  • Pinnacle Clinical Research, PLLC

    lead OTHER

Principal Investigators

  • Stephen Harrison, MD · Pinnacle Clinical Research

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2020-11-25
Completion
2020-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03656068 on ClinicalTrials.gov