UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oral L-Carnitine Treatment in Hepatic Encephalopathy
Title of the study (Brief title)	Oral L-Carnitine Stydy
Region	Japan

Condition
Condition	hepatic encephalopathy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	L-carnitine treatment is associated with a significant reduction of blood and brain ammonia concentration. To evaluate the influence of L-carnitine on the patients with recurrent hepatic encephalopathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The time to the first breakthrough episode of overt hepatic encephalopathy (>=grade 2).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral L-cartine treatment
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patient's age ranges from 20 to 80 years. 2. At least two episodes of overt hepatic encephalopathy (>=Grade 2) associated with hepatic cirrhosis during the previous 6 months, and remission (Grade 0 or 1) at enrollment. 3. Patient's prognosis should be longer than 6 months. 4. In-and Outpatients 5. Patients received document agreement with participation in this study.
Key exclusion criteria	1. Patient's prognosis is shorter than 6 months. 2. Child Pugh grade C 3. Spontaneous bacterial peritonitis 4. Alcoholism or antipsychotic drug user 5. Gastrointestinal hemorrhage 6. The placement of TIPS, B-RTO, or PSE. 7. Patients who judged inappropriate by researcher.
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshitaka Takuma
Organization	Kurashiki Central Hospital
Division name	Gastroenterology
Address	1-1-1 Miwa, Kurashiki, Okayama 710-8602 Japan
TEL
Email

Public contact
Name of contact person	Yukari Matsumoto
Organization	Kurashiki Central Hospital
Division name	Gastroenterology
Address
TEL
Homepage URL
Email

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	Kurashiki Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2013 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 12 Month 11 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 11 Day
Last modified on	2018 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011437