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NCT03656068 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Fatty Liver and Non-alcoholic Steatohepatitis, sponsored by Pinnacle Clinical Research, P.

Completed
Registry status
Phase 2
Development phase
21
Enrollment target
1
Study location

NCT03656068 is a Phase 2 study of Fatty Liver and Non-alcoholic Steatohepatitis that has completed, run by Pinnacle Clinical Research, P. The registered enrollment target is 21 participants, below the 210-participant average among 20 other Fatty Liver trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03656068, a Phase 2 study of Fatty Liver and Non-alcoholic Steatohepatitis, has completed, sponsored by Pinnacle Clinical Research, P.

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target
1
Study location

Study 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 Studied

Fatty Liver Non-alcoholic Steatohepatitis Fibrosis, Liver Compensated Cirrhosis

Interventions

  • DRUG Nitazoxanide 500mg BID

Study Locations (1)

Texas

  • Pinnacle Clinical Research - San Antonio

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2018-12-04
Est. Completion 2020-11-25
Phase Phase 2

Sponsor

Pinnacle Clinical Research, P

1 total trials

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What the Registry Record Tells You About NCT03656068

The ClinicalTrials.gov registry entry for NCT03656068 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 210-participant average among 20 other Fatty Liver trials with a reported enrollment target (90% lower). The listed sponsor is Pinnacle Clinical Research, P, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Fatty Liver appearing as the primary indexed condition, and to 1 intervention - of which Nitazoxanide 500mg BID is the first listed.

NCT03656068 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03656068 about?

NCT03656068 is a clinical study titled "An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis". 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

What is the current status of trial NCT03656068?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-12-04. Estimated completion is 2020-11-25.

What conditions does trial NCT03656068 study?

This clinical trial studies the following conditions: Fatty Liver, Non-alcoholic Steatohepatitis, Fibrosis, Liver, Compensated Cirrhosis.

What interventions are being tested in trial NCT03656068?

The interventions under investigation include: Nitazoxanide 500mg BID (DRUG).

Who is sponsoring clinical trial NCT03656068?

This trial is sponsored by Pinnacle Clinical Research, P, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03656068 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.