Alcohol-related liver disease and nalmefene

JRCT ID: jRCT1031220022

Registered date:14/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alcohol related liver disease
• Date of first enrollment: 14/04/2022
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Nalmefene hydrochloride is orally administered at 10 mg 1-2 hours before drinking alcohol once daily for 24 weeks

Outcome(s)

• Primary Outcome: Change of serum GGT 24 weeks after the start of the treatment with nalmefene

Secondary Outcome

(1) Change of serum AST, ALT, ALP, GGT, LD, and ferritin 4, 8, 12, 24, 36weeks and AST, ALT 48 weeks after the start of the treatment with nalmefene
(2) Change of alcohol consumption and serum carbohydrate-deficient transferrin/total transferrin (%CDT)4, 8, 12, 24, 36, 48 weeks after the start of the treatment with nalmefene
(3) type IV collagen, M2BPGi, and Fib4 index
(4) PT/INR, TP, Alb, ChE, T-bil
(5) Adherence
(6) Alcohol consumption
(7) Adverse effects
(8) Treatment continuation rate after the end of the administration period for 24 weeks and alcohol consumption, %CDT value, serum AST, ALT, and GGT value depending on the presence or absence of treatment continuation
(9) CAP, liver stiffness
(10) Body fat percentage, visceral fat level, skeletal muscle mass, total body water, and fat mass
(11) fasting plasma glucose (FPG), insulin
(12) triacylglycerol (TG), non-esterified fatty acid, HDL-cholesterol, LDL-cholesterol
(13) Correlation between decreased carbohydrate-deficient transferrin/total transferrin (%CDT) and decreased serum AST, ALT and GGT levels

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Outpatients aged 20 to 80
2) Patients who have a heavy drinking habit exceeding 60 g / day for men and 40 g / day for women in terms of pure alcohol and meet the diagnostic criteria of the ICD-10 diagnostic guidelines for alcohol dependence syndrome
3) Patients who did not abstain from alcohol after the pre-observation period (4 to 12 weeks) and had a serum GGT level of 100 IU / L or higher
4) Patients who have written consent to participate in this study

Exclude criteria

1) Patients treated for viral hepatitis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis or metabolic liver disease)
2) Patients with decompensated cirrhosis (Child-Pugh grade C)
3) Patients who are taking contraindications of nalmefene such as opioids
4) Patients with advanced or malignant tumor requiring treatment
5) Pregnant or suspected pregnant, lactating patients
6) Patients judged to be ineligible by a doctor

Related Information

• Primary Sponsor: Ikejima Kenichi