NCT03656068|CompletedPhase 2ResultsDMCFDA Drug
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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
Sponsor study identifier
interventional
21
1 country
1
Study Start
December 4, 2018
Actual (reported)Primary Completion
November 25, 2020
Actual (reported)Study Completion
November 25, 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 25, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 29, 2018
Actual (reported)September 4, 2018
Actual (reported)December 4, 2018
Actual (reported)November 25, 2020
Actual (reported)November 25, 2020
Actual (reported)June 30, 2022
Actual (reported)Number of NTZ Treated Participants Presenting Any Treatment Emergent Adverse Event (TEAE)
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of treatment-emergent adverse events (TEAEs).
28 weeks
Number of NTZ Treated Participants Presenting Any Study Drug Related TEAE
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related treatment-emergent adverse events (TEAEs).
28 weeks
Number of NTZ Treated Participants Presenting Any SAE
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of serious adverse events (SAEs).
28 weeks
Number of NTZ Treated Participants Presenting Study Drug-Related SAE
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related serious adverse events (SAEs).
Change in Lumican Fractional Synthesis Rate (FSR) From Baseline to End of Treatment
From baseline to end of treatment (Visit 10, Week 24 or early termination)
Percent Change in Lumican Fractional Synthesis Rate (FSR) From Baseline to End of Treatment
From baseline to end of treatment (Visit 10, Week 24 or early termination)
Change in Transforming Growth Factor Beta-induced Protein (TGFBI) FSR From Baseline to End of Treatment
From baseline to end of treatment (Visit 10, Week 24 or early termination)
Percent Change in Transforming Growth Factor Beta-induced Protein (TGFBI) FSR From Baseline to End of Treatment
From baseline to end of treatment (Visit 10, Week 24 or early termination)
Change in Controlled Attenuation Parameter (CAP) Score From Baseline to End of Treatment as Evaluated by FibroScan®
24 weeks
Open label. All patients will receive study drug
Patients will receive 500mg of Nitazoxanide BID daily for 24 weeks
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
Stephen Harrison, MD
Pinnacle Clinical Research
21 participants (actual enrollment reported by the registry).
First Submitted
August 29, 2018
First Posted
September 4, 2018
Study Start
December 4, 2018
Actual (reported)Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B
28 weeks
Deaths Due to AE
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of deaths due to adverse events (AEs).
28 weeks
Number of NTZ Treated Participants Presenting Any AE Leading to Withdrawal From Study or Study Drug
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of adverse events (AEs) leading to withdrawal from study or study drug.
28 weeks
Number of NTZ Treated Participants Presenting Any Study Drug-related AE Leading to Withdrawal From Study or Study Drug
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of study drug-related adverse events (AEs) leading to withdrawal from study or study drug
28 weeks
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Clinical Laboratory Evaluations
To assess the safety and tolerability of NTZ after 24 weeks of treatment by performing clinical laboratory evaluations. Changes in clinical laboratory evaluations were considered clinically significant or not as per Investigator judgment.
28 weeks
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Vital Signs
To assess the safety and tolerability of NTZ after 24 weeks of treatment by measuring vital signs. Changes in vital signs were considered clinically significant or not as per Investigator judgement
28 weeks
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Electrocardiogram Parameters
To assess the safety and tolerability of NTZ after 24 weeks of treatment by performing electrocardiograms (ECGs). Changes in ECGs parameters were considered clinically significant or not as per Investigator judgement.
28 weeks
Number of NTZ Treated Participants Presenting at Least One Clinically Significant (CS) Change in Physical Examinations
To assess the safety and tolerability of NTZ after 24 weeks of treatment by conducting physical examinations. Changes in physical examinations were considered clinically significant or not as per Investigator judgement.
28 weeks
Contact the study team to confirm eligibility.
Primary Completion
November 25, 2020
Actual (reported)Study Completion
November 25, 2020
Actual (reported)Last Updated
June 30, 2022
Results First Posted
June 30, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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