Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems (NCT07480096) | Clinical Trial Compass
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 range18 Years
SexALL
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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…
What they're measuring
1
Sleep quality
Timeframe: From enrollment to the end of treatment at 2 weeks