CompletedPhase 2

Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems

Indonesia82 participantsStarted 2024-10-01

Plain-language summary

Sleep disturbance poses significant in patients with liver cirrhosis and is associated with impaired quality of life and worsening clinical status. Current pharmacological options remain limited and often have safety concerns due to altered hepatic metabolism. Lemborexant, a dual orexin receptor antagonist, promotes physiological sleep by inhibiting orexin-mediated wakefulness pathways. This study aims to evaluate the efficacy and safety of lemborexant for improving sleep in patients with liver cirrhosis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * adults aged 18 years or older; * willingness to participate in the clinical trial as evidenced by written informed consent; documented diagnosis of liver cirrhosis in the medical record, with disease severity assessed using the Child-Pugh score and supported by imaging findings consistent with cirrhosis on FibroScan or ultrasonography; * presence of sleep disturbance defined by a Pittsburgh Sleep Quality Index (PSQI) score greater than 5; * patients receiving inpatient or outpatient care at Cipto Mangunkusumo National General Hospital; * ability to take oral medication; * willingness of the patient or caregiver to maintain a sleep diary throughout the study period; * ability of the patient or caregiver to comply with the clinical trial protocol and complete scheduled serial assessments. Exclusion Criteria: * advanced liver cirrhosis defined as Child-Pugh class C; * current use of medications with significant interactions affecting the metabolism of Lemborexant, including itraconazole, clarithromycin, fluconazole, verapamil, tramadol, rifampicin, carbamazepine, bosentan, efavirenz, etravirine, and modafinil; * ongoing alcohol consumption or intake of grapefruit juice during the study period; * pregnancy, breastfeeding, or plans to become pregnant during the study; * presence of significant comorbid conditions such as autoimmune disease, * stage V chronic kidney disease, HIV/AIDS, or known or suspected hypersensitivity to the investigational drug; * con…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sleep quality

Timeframe: From enrollment to the end of treatment at 2 weeks

Trial details

NCT IDNCT07480096

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Cirrhosis trials