A Phase 4 interventional study of Daridorexant and Placebo in Liver Cirrhosis, Sleep Disturbance and Hepatic Encephalopathy, sponsored by Wang Fengmei. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Wang Fengmei · Phase 4, Interventional, and Treatment
This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy. Sleep disturbance is common in people with liver cirrhosis and may affect quality of life and cognitive function. Participants will be randomly assigned to receive either daridorexant or a matching placebo for 30 days. Neither participants nor study investigators will know which treatment is assigned during the study, except when unblinding is medically necessary. Sleep and cognitive function will be assessed during the study using sleep monitoring, the Psychometric Hepatic Encephalopathy Score (PHES), and the Stroop EncephalApp, together with other clinical and laboratory assessments. The main purpose of the study is to determine whether daridorexant improves sleep efficiency compared with placebo after 30 days. The study will also evaluate changes in sleep quality, sleep structure, cognitive function, the occurrence or improvement of covert hepatic encephalopathy, and the safety of daridorexant. A total of 180 participants are planned to be enrolled at multiple participating hospitals and will be randomly assigned in a 1:1 ratio to daridorexant or placebo.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 180 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →This is the only study on the registry with Wang Fengmei as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral daridorexant once nightly for 30 days. The dose will be 25 mg or 50 mg according to liver function and the study protocol. For participants with Child-Pugh class B liver function, the dose will not exceed 25 mg per night.
Drug: Daridorexant
Participants will receive matching placebo orally for 30 days.
Drug: Placebo
Daridorexant tablets administered orally once nightly for 30 days at a dose of 25 mg or 50 mg according to liver function and the study protocol. The maximum dose for participants with Child-Pugh class B liver function is 25 mg per night.
Matching placebo administered orally once daily for 30 days.
Percent Improvement From Baseline in Sleep Efficiency at Day 30
Sleep efficiency (SE) is measured by overnight polysomnography (PSG) and expressed as the percentage of time in bed spent asleep. PSG is performed at baseline and on Days 7, 14, and 30. The primary outcome is the relative percent change in SE from baseline to Day 30.
Time frame: Baseline and Day 30
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at Day 30
The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The outcome is the change in the PSQI total score from baseline to Day 30.
Time frame: Baseline and Day 30
Change From Baseline in Polysomnography-Measured Sleep Latency at Day 30
Sleep latency is measured by overnight polysomnography (PSG), in minutes, from lights out to sleep onset. PSG is performed at baseline and on Days 7, 14, and 30. This outcome is calculated as Day 30 sleep latency minus baseline sleep latency; negative values indicate a shorter time to fall asleep.
Time frame: Baseline and Day 30
Change From Baseline in Total Sleep Time at Day 30
Total sleep time is the total duration of sleep recorded during overnight polysomnography (PSG), expressed in minutes. PSG is performed at baseline and on Days 7, 14, and 30. This outcome is calculated as Day 30 total sleep time minus baseline total sleep time; positive values indicate a longer sleep duration.
Time frame: Baseline and Day 30
Change From Baseline in Slow-Wave Sleep Percentage at Day 30
Slow-wave sleep (SWS) is defined as stage N3 sleep measured by overnight polysomnography (PSG). SWS percentage is calculated as N3 sleep time divided by total sleep time, multiplied by 100. PSG is performed at baseline and on Days 7, 14, and 30. This outcome is the Day 30 SWS percentage minus the baseline SWS percentage, expressed in percentage points.
Time frame: Baseline and Day 30
Change From Baseline in Rapid Eye Movement Sleep Percentage at Day 30
Rapid eye movement (REM) sleep is measured by overnight polysomnography (PSG). REM sleep percentage is calculated as REM sleep time divided by total sleep time, multiplied by 100. PSG is performed at baseline and on Days 7, 14, and 30. This outcome is the Day 30 REM sleep percentage minus the baseline REM sleep percentage, expressed in percentage points.
Time frame: Baseline and Day 30
Change From Baseline in Microarousal Frequency at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Psychometric Hepatic Encephalopathy Score During Treatment
The Psychometric Hepatic Encephalopathy Score (PHES) ranges from -15 to +5, with higher scores indicating better cognitive performance. The outcome is the change in PHES during the study.
Time frame: Baseline, Day 7, Day 14, and Day 30
Change From Baseline in Stroop EncephalApp Performance at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Epworth Sleepiness Scale Total Score at Day 30
Time frame: Baseline and Day 30
Proportion of Participants With Reversal of Minimal Hepatic Encephalopathy by Day 30
Time frame: Baseline through Day 30
Proportion of Participants With New-Onset Minimal Hepatic Encephalopathy Through Day 30
Time frame: Baseline through Day 30
Incidence of Overt Hepatic Encephalopathy by Day 30
Time frame: From baseline through Day 30
Proportion of Participants With Adverse Events
Time frame: From treatment initiation through Day 30
Proportion of Participants With Serious Adverse Events
Time frame: From treatment initiation through Day 30
Proportion of Participants Discontinuing Study Treatment Due to Adverse Events
Time frame: From treatment initiation through Day 30
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2029, 29 months later.
Of 36 phase 4 interventional studies under Liver Cirrhosis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 13. This study's planned 29 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Daridorexant