UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of carnitine for chronic liver disease or liver cirrhosis with hyperammonemia
Title of the study (Brief title)	The effect of carnitine for hyperammonemia
Region	Japan

Condition
Condition	Chronic liver disease with hyperammonemia
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To make clear the dfffect of carnitine for hypaerammonemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decrease of ammonia after carnitine administration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	standard therapy treated generaly
Interventions/Control_2	carnitine administration (1000mg/day, 3 months)
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	1.Informed consent was obtained 2.Patients has not receive carnitine before 2 weeks 3.chronic liver damage and liver cirrhosis who has serum ammonia more than 60ug/dL 4.hepatic encephalopathy or positive of number conection test B
Key exclusion criteria	1.GI tract bleeding 2.Patients experienced adverse events 3.Giant shunt of vessels 4.dementia 5.malignat tumor which is uncontroled 6.Allergic reaction for carnitine 7.Patients who administrate drugs that introduce hyperammonemia 8.Patients receive dialysis 9.Patients who is pregnant
Target sample size	140

Research contact person
Name of lead principal investigator	Shunsuke Nojiri
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL	+81-52-853-8211
Email	snojiri@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Shunsuke Nojiri
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL	+81-52-853-8211
Homepage URL
Email	snojiri@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2016 Year 11 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 08 Day
Anticipated trial start date	2016 Year 04 Month 26 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	2016 Year 11 Month 29 Day
Last modified on	2016 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028798