CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Nitazoxanide 500mg BIDdrug
Likely dose
Nitazoxanide 500mg BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03656068
NCT03656068Phase 2Completed
CompareCT.gov

A Monocentric, Open-Label, Proof of Concept Study to Evaluate the Safety and Efficacy of Nitazoxanide at 500mg Twice Daily on Collagen Turnover in Plasma in NASH Patients With Fibrosis Stage 2 or 3

Pinnacle Clinical Research, PLLC·interventional·Posted Sep 4, 2018·Updated Jun 30, 2022

In Brief

A Phase 2 clinical trial evaluating Nitazoxanide 500mg BID for Non-alcoholic Steatohepatitis and 3 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Steatohepatitis, Fatty Liver, Fibrosis, Liver, Compensated Cirrhosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 4, 2018
Enrollment StartDec 4, 2018
Primary CompletionNov 25, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.8 years ago

Interventions

Nitazoxanide 500mg BIDdrug

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