UMIN-CTR Clinical Trial

Basic information
Public title	The investigation for the usefulness of carnitine medication in patients with decompensated liver cirrhosis
Acronym	The usefulness of carnitine medication in patients with decompensated liver cirrhosis
Scientific Title	The investigation for the usefulness of carnitine medication in patients with decompensated liver cirrhosis
Scientific Title:Acronym	The usefulness of carnitine medication in patients with decompensated liver cirrhosis
Region	Japan

Condition
Condition	decompensated liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	the improvement rate of Child-Pugh score after 12weeks from medication start
Key secondary outcomes	the change of grasping power, muscle mass, serum ammonia, neuropsychological test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	L-carnitine 1500mg/day medication for 12 weeks
Interventions/Control_2	non administration group
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The decompensated liver cirrhosis patients with Child-Pugh score over 7 points
Key exclusion criteria	1)The patient who has already taken carnitine 2)The pregnant woman 3)The breast-feeding women 4)The patient who received other study medicine or the clinical experimental medicine within three months before dosage start of the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Akinobu Middle name Last name Takaki
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code	7008558
Address	2-5-1 Sikatacho, Kitaku, Okayama city, Okayama, japan
TEL	086-235-7219
Email	akitaka@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Adachi
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code	7008558
Address	2-5-1 Sikatacho, Kitaku, Okayama city, Okayama, japan
TEL	086-235-7219
Homepage URL
Email	adataku719@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	epartment of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address	2-5-1 Sikatacho, Kitaku, Okayama city, Okayama, japan
Tel	086-235-6610
Email	chiken@okayama-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 01 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	0
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	Terminated
Date of protocol fixation	2020 Year 07 Month 28 Day
Date of IRB	2020 Year 07 Month 28 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 18 Day
Last modified on	2020 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046141

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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