NCT03656068

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Pinnacle Clinical Research, PLLC · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Based on the anti-fibrotic properties demonstrated in the animal models of fibrosis, this proof of concept clinical study aims at evaluating NTZ in patients with non-alcoholic steatohepatitis (NASH) and fibrosis stage 2 and 3. Although NTZ has been evaluated in liver disease populations up to 60 weeks, this is the first study evaluating NTZ treatment in a population with NASH induced stage 2 and 3 fibrosis. The aim of this study is to evaluate the safety and tolerability of NTZ 500 mg BID after 24 weeks of treatment in this population. This proof of concept study will also evaluate the anti-fibrotic effect of NTZ as a secondary objective. The methods of evaluation of fibrosis will include an innovative method of metabolic labeling.This approach is based on the concept that liver status can be determined by measuring the ratio of newly synthesized/pre-existing proteins.The turn-over rate of newly synthesized collagen and proteins represents the hepatic fibrogenic disease activity. Patients will be given "heavy water" to drink. Heavy water contains D20, deuterium being a stable isotope of hydrogen. Mass spectrometry is used to identify individual proteins and to quantify the ratio of labeled protein to total protein. The results are expressed as fractional synthesis rate of these proteins (FSR). This method has been previously published (Decaris et al, 2017). Other non-invasive methods will be used to evaluate the liver stiffness changes after NTZ treatment: Magnetic Resonance Elastography (MRE) and FibroScan®.

Conditions

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

Interventions

Type	Name	Description
DRUG	Nitazoxanide 500mg BID	Patients will receive 500mg of Nitazoxanide BID daily for 24 weeks

Timeline

• Start date: 2018-12-04
• Primary completion: 2020-11-25
• Completion: 2020-11-25
• First posted: 2018-09-04
• Last updated: 2022-06-30
• Results posted: 2022-06-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study