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Antiparasitic

Nitazoxanide for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Genfit
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up plasma:day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose urine:day-1: pre-dose, day 1: 24 hours urine collection post-dose; day 7: 48 hours urine collection
Awards & highlights

Study Summary

This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with hepatic impairment and healthy adults.

Eligible Conditions
  • Liver Impairment
  • Liver Damage
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~plasma:day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose urine:day-1: pre-dose, day 1: 24 hours urine collection post-dose; day 7: 48 hours urine collection
This trial's timeline: 3 weeks for screening, Varies for treatment, and plasma:day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose urine:day-1: pre-dose, day 1: 24 hours urine collection post-dose; day 7: 48 hours urine collection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
Area under the plasma concentration time curve (AUC) from time zero to 12h (AUC0-12)
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
Plasma and urine pharmacokinetics: After the single oral administration of NTZ 500 mg: Cmax, AUC0-12, AUC0-t, AUC0-∞ , Tmax, t1/2, %AUCextrap, Ae0-∞, Ae0-t and CLR.
Plasma pharmacokinetics: Tmax, AUC0-12, AUC0-t, AUC0-∞, Cmax, t1/2, %AUCextrap and Ctrough.
Plasma pharmacokinetics: time of the maximum observed plasma concentration (Tmax), apparent plasma terminal elimination half life (t1/2), AUC from time zero to infinity (AUC0-∞), trough concentration (Ctrough) and percentage of extrapolated (%AUCextrap)
+1 more

Side effects data

From 2019 Phase 3 trial • 1030 Patients • NCT03336619
15%
Chromaturia
7%
Diarrhoea
2%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nitazoxanide

Trial Design

3Treatment groups
Experimental Treatment
Group I: Severe Child-Pugh C (Severe hepatic impairment)Experimental Treatment1 Intervention
NTZ 500 mg twice a day for 7 days
Group II: Moderate Child-Pugh B (Moderate hepatic impairment)Experimental Treatment1 Intervention
NTZ 500 mg twice a day for 7 days
Group III: Healthy Control Match (Normal hepatic function)Experimental Treatment1 Intervention
NTZ 500 mg twice a day for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitazoxanide
2013
Completed Phase 4
~8390

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GenfitLead Sponsor
19 Previous Clinical Trials
3,480 Total Patients Enrolled
Carol Addy, MDStudy DirectorGenfit
1 Previous Clinical Trials
77 Total Patients Enrolled
~7 spots leftby Jun 2025
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