Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure (CONTROL-ACLF)

A Phase 2, Multicenter, Open-label Study to Evaluate Safety and Efficacy of 500 mg BID NTZ on Top of Standard of Care in Patients With Inflammatory Phenotype Presenting Either With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure (CONTROL-ACLF)

Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients with Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Decompensation of Liver Cirrhosis; Established Acute-on-Chronic Liver Failure
• Intervention / Treatment: Drug: NTZ 500mg BID on top of SOC

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pejvack Motlagh, MD, MSc; Phone Number: +333 20 16 40 00; Email: contact@genfit.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

• Participants with liver cirrhosis of any underlying etiology (liver cirrhosis diagnosed by standard clinical criteria, imaging findings, and/or histology)
• Recent acute clinical deterioration within 10 days prior to Day 1 defined as the onset of ascites, HE, gastrointestinal bleeding, or any combination of them with or without infection with or without organ failure
• Adult male or female participants, defined as having reached the legal age of majority according to local regulations, aged <75 years on the day of signing informed consent form (ICF)
• Participants or legal representative willing and able to provide written informed consent in accordance with local ethical and legal requirements
• Participants able to swallow peroral medication

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Known hypersensitivity to nitazoxanide or any known excipient of the IMP
2. Nitazoxanide use within 30 days prior to SCR
3. Uncontrolled acute bleeding at SCR or Day 1
4. Participants with poorly controlled seizure disorder
5. Severe circulatory failure requiring the use of high dose vasopressors (eg, dopamine >15 μg/kg/min, or epinephrine >0.1 μg/kg/min, or norepinephrine >0.1 μg/kg/min); the use of terlipressin or low dose norepinephrine to treat hepatorenal syndrome is not an exclusion criterion
6. Uncontrolled severe infection with hemodynamic instability or shock
7. Need for renal replacement therapy (RRT) or any extracorporeal liver support device
8. Any significant disease considered to be potentially detrimental or would preclude the participant from participating in and completing the study as assessed by the PI
9. Individuals for whom the PI deems that study participation would be unsafe or not in the interest of the participant
10. Pregnancy or lactation
11. Participants of childbearing potential and non-sterile male participants who are not willing to use adequate contraception from SCR to 90 days after the final dose of IMP
12. Participation in another interventional clinical study within 30 days of SCR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NTZ 500mg BID on top of SOC; Treatment period NTZ 500mg BID on top of SOC during 7 days.	Drug: NTZ 500mg BID on top of SOC; Treatment period NTZ 500mg BID on top of SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of 500 mg BID NTZ administered perorally	Safety defined as the incidence, relatedness, and severity (NCI-CTCAE v6.0 grade) of TEAEs including SAEs (comprising the evaluation of vital signs, ECGs, and laboratory parameters).	over 7 days on top of SOC follow-up period up to Day 28.

Collaborators and Investigators

• Sponsor: Genfit

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: bis in die twice a day, BID; Nitazoxanide, NTZ; Standard of Care, SOC; Acute-on-Chronic Liver Failure, ACLF; Acute Decompensation, AD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute; Acute-On-Chronic Liver Failure; nitazoxanide
• Other Study ID Numbers: NTZ_P2_26_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No