Acute Decompensation of Liver CirrhosisPhase 2CONTROL-ACLFNCT07694297
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
A Phase 2 study testing NTZ 500mg BID on top of SOC in people with Acute Decompensation of Liver Cirrhosis and Established Acute-on-Chronic Liver Failure, run by Genfit.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Acute Decompensation of Liver Cirrhosis, Established Acute-on-Chronic Liver Failure
- What is being tested?
- NTZ 500mg BID on top of SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Known hypersensitivity to nitazoxanide or any known excipient of the IMP
- Nitazoxanide use within 30 days prior to SCR
- Uncontrolled acute bleeding at SCR or Day 1
- Participants with poorly controlled seizure disorder
- 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
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- Uncontrolled severe infection with hemodynamic instability or shock
- Need for renal replacement therapy (RRT) or any extracorporeal liver support device
- 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
- Individuals for whom the PI deems that study participation would be unsafe or not in the interest of the participant
- Pregnancy or lactation
- 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
- Participation in another interventional clinical study within 30 days of SCR.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Being tested
- NTZ 500mg BID on top of SOC
- Keywords
- bis in die twice a day, BID, Nitazoxanide, NTZ, Standard of Care, SOC, Acute-on-Chronic Liver Failure, ACLF, Acute Decompensation, AD
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTZ 500mg BID on top of SOCDrug
Treatment period NTZ 500mg BID on top of SOC
| Study group | Role | What they receive |
|---|---|---|
| NTZ 500mg BID on top of SOC | Experimental | Treatment period NTZ 500mg BID on top of SOC during 7 days. Receives: Drug: NTZ 500mg BID on top of SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: over 7 days on top of SOC follow-up period up to Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensation of Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694297
- Sponsor's protocol ID
- NTZ_P2_26_1
- Acronym
- CONTROL-ACLF
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07694297
- Acronym / sponsor ID
- CONTROL-ACLF / NTZ_P2_26_1
- Keywords
- bis in die twice a day, BID, Nitazoxanide, NTZ, Standard of Care, SOC, Acute-on-Chronic Liver Failure, ACLF, Acute Decompensation, AD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTZ 500mg BID on top of SOC | Experimental | Drug: NTZ 500mg BID on top of SOCTreatment period NTZ 500mg BID on top of SOC during 7 days. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Known hypersensitivity to nitazoxanide or any known excipient of the IMP
- Nitazoxanide use within 30 days prior to SCR
- Uncontrolled acute bleeding at SCR or Day 1
- Participants with poorly controlled seizure disorder
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTZ 500mg BID on top of SOCTreatment period NTZ 500mg BID on top of SOC | Drug | NTZ 500mg BID on top of SOC |
Primary outcome
To evaluate the safety of 500 mg BID NTZ administered perorally
Time frame: over 7 days on top of SOC follow-up period up to Day 28.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTZ 500mg BID on top of SOC in people with Acute Decompensation of Liver Cirrhosis and Established Acute-on-Chronic Liver Failure, run by Genfit.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pejvack Motlagh, MD, MSc (+333 20 16 40 00, contact@genfit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of 500 mg BID NTZ administered perorally (time frame: over 7 days on top of SOC follow-up period up to Day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.