UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists
Acronym	Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists
Scientific Title	Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists
Scientific Title:Acronym	Effects of Nalmefene on Reduction of Drinking Alcohol and Improvement of Liver Function/Quality of Life in Patients with Alcoholic Liver Disease Treated mainly by Hepatologists
Region	Japan

Condition
Condition	Alcoholic Liver Injury, Alcohol Dependence
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Long-term excessive alcohol consumption is a cause of alcoholic hepatitis and cirrhosis, and prognosis has been reported to improve with abstinence from alcohol. On the other hand, the rate at which abstinence from alcohol can be achieved is low and the rate of relapse is high. Nalmefene is a drug that reduces alcohol consumption in alcohol-dependent patients by suppressing the desire to drink through the modulation of opioid receptors that are widely present in the central nervous system. Unlike existing abstinence drugs, nalmefene is designed to reduce alcohol consumption and has been proven to reduce alcohol consumption for long time and to achieve subsequent sobriety, but its effects on improving liver function, adherence, and quality of life in patients with alcoholic liver disease have not been reported. In addition, many patients with alcoholic liver disease have co-occurring alcoholism, but only 22% of respondents have "ever received psychiatric treatment for alcoholism," and psychiatric bridges have not been realistically established. Nalmefene is a drug that can be prescribed by physicians who have taken a training course. The treatment is started in internal medicine for patients who wish to reduce their alcohol consumption but have been unsuccessful in abstinence. Then, a bridge to psychiatric treatment can be made, which may lead to higher treatment efficacy. The efficacy of nalmefene in patients with alcoholic liver disease should be confirmed by evaluating whether or not they can achieve sobriety and whether or not their liver function improves when they do achieve sobriety. If the efficacy of nalmefene can be shown in patients who are currently unable to abstain from alcohol, it will contribute to the improvement of liver function in more patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in Aspartate aminotransferase (AST) after 12, 24 weeks
Key secondary outcomes	Change in the following parameters after 12.24 weeks Changes in liver function (ALT, albumin, gamma-glutamyl transpeptidase, Albumin-Bilirubin score, Cihld-Pugh Score) Alcohol consumption (average alcohol consumption, heavy drinking days, days off drinking) Incidence of events requiring hospitalization Medication adherence rate Degree of alcohol dependence (AUDIT) Quality of life (A-QOL) based on a questionnaire index Well-being (Clinical Global Impression-Severity of Illness: CGI-S) Incidence of adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients 20 years of age or older, Patients with alcoholic liver disease diagnosed as alcohol dependence based on DSM-IV-TR ICD-10. Patients who have decided to start treatment with nalmefene, Patients who understand the study and have given written consent. Patients who have difficulty abstaining from alcohol but are willing to try to reduce alcohol consumption on their own.
Key exclusion criteria	Patients with a history of hypersensitivity to the nalmefene component. Patients receiving opioids (analgesics, anesthetics) or within 1 week of discontinuation of opioid therapy Patients with acute symptoms of opioid dependence or withdrawal Patients who wish to be excluded from the study, Patients who cannot provide written consent Patients experiencing withdrawal symptoms, depressive symptoms or suicide attempts. Patients deemed inappropriate by the attending physician or principal/assistant investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masatoshi Middle name Last name Ishigami
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	466-8550
Address	65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-741-2111
Email	mtfujish@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Yamamoto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	466-8550
Address	65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-741-2111
Homepage URL
Email	kenta-y@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Address	65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
Tel	052-741-2111
Email	052-741-2111

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2022 Year 06 Month 27 Day
Last modified on	2022 Year 06 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054906