UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025034
Receipt number R000028798
Scientific Title The effect of carnitine for chronic liver disease or liver cirrhosis with hyperammonemia
Date of disclosure of the study information 2016/11/29
Last modified on 2016/11/29 00:29:18

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Basic information

Public title

The effect of carnitine for chronic liver disease or liver cirrhosis with hyperammonemia

Acronym

The effect of carnitine for hyperammonemia

Scientific Title

The effect of carnitine for chronic liver disease or liver cirrhosis with hyperammonemia

Scientific Title:Acronym

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

1st name
Middle name
Last name Shunsuke Nojiri

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code


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

1st name
Middle name
Last name Shunsuke Nojiri

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code


Address

1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya

TEL

+81-52-853-8211

Homepage URL


Email

snojiri@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Open public recruiting

Date of protocol fixation

2016 Year 04 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028798


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name