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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027511
Receipt No. R000031535
Scientific Title Combination therapy with levocarnitine and rifaximin for hepatic encephalopathy in patients with cirrhosis: a randomized study
Date of disclosure of the study information 2017/06/07
Last modified on 2017/05/28

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Basic information
Public title Combination therapy with levocarnitine and rifaximin for hepatic encephalopathy in patients with cirrhosis: a randomized study
Acronym Combination therapy with levocarnitine and rifaximin for liver encepharopaty
Scientific Title Combination therapy with levocarnitine and rifaximin for hepatic encephalopathy in patients with cirrhosis: a randomized study
Scientific Title:Acronym Combination therapy with levocarnitine and rifaximin for liver encepharopaty
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy of combination therapy with levocarnitine and rifaximin for hepatic encephalopathy in patients with cirrhosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood ammonia concentration
Key secondary outcomes (1) PSE score
(2) Number connection test-A
(3) Number connection test-B
(4) Quality of life

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 Combination therapy with levocarnitine and rifaximin
Interventions/Control_2 Monotherapy with rifaximin
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 Hepatic encephalopathy
Positive of number conection test A
Grade 1 West Haven criteria
Serum ammonia more than 80ug/dL
2 Liver cirrhosis
3 Carnitine deficiency
4 Informed consent was obtained
Key exclusion criteria 1 Psychiatric disorder which is uncontrolled
2 Acute liver failure
3 Rapture of esophagus varices
4 Spontaneous bacterial peritonitis
5 Laboratory abnormalities
-T-bil>5.0mg/dL
-Cre>2.0mg/dL
-Hb <8.0g/dL


Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Uojima Haruki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL 042-778-8390
Email kiruha@kitasato-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Uojima Haruki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL 042-778-8390
Homepage URL
Email kiruha@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato University School of Medicine
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
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
2017 Year 06 Month 07 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
2017 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 07 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
2017 Year 05 Month 28 Day
Last modified on
2017 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031535

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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