UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036998 |
|---|---|
| Receipt number | R000042151 |
| Scientific Title | Randomized controlled trial comparing zinc-rifaximin combination therapy with zinc monotherapy in liver cirrhosis patients with minimal hepatic encephalopathy |
| Date of disclosure of the study information | 2019/06/10 |
| Last modified on | 2021/07/09 14:17:01 |
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Basic information
Public title
Randomized controlled trial comparing zinc-rifaximin combination therapy with zinc monotherapy in liver cirrhosis patients with minimal hepatic encephalopathy
Acronym
Rifaximin-containing combination vs single-agent zinc in liver cirrhosis patients with minimal hepatic encephalopathy(MHE/zinc-rifa vs zinc )
Scientific Title
Randomized controlled trial comparing zinc-rifaximin combination therapy with zinc monotherapy in liver cirrhosis patients with minimal hepatic encephalopathy
Scientific Title:Acronym
Rifaximin-containing combination vs single-agent zinc in liver cirrhosis patients with minimal hepatic encephalopathy(MHE/zinc-rifa vs zinc )
Region
| Japan |
Condition
Condition
Liver cirrhosis with minimal hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the synergistic therapeutic effect of zinc and rifaximin on minimal hepatic encephalopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of number connection test B (NCT-B)
Key secondary outcomes
1)Neuro-Psychological Tests (NCT-A, B, Figure position test, Digit symbol test, Block design test, Stroop test)
2)Achievement rate of serum zinc>80mcg/dl
3)Value, changes of serum zinc
3)Time to first breakthrough overt hepatic encephalopathy episode
4)Time to first hepatic encephalopathy-related hospitalization
5)Overall survival
6)Subgroup analysis of 2)3) classified by patients characteristics(Child-Pugh score, MELD score, FIB-4 index, Skeletal muscle index)
7) Improvement of high signal of head MRI T1-weighted image in the basal ganglia pallidus
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Zinc (50mg/day) + rifaximin (120mg/day). For cases with the serum zinc level is less than 80 mcg/dl at 8 weeks of administration, the amount of zinc is increased to 100mg/day. Total administration period is 12 weeks.
Interventions/Control_2
Zinc (50mg/day). For cases with the serum zinc level is less than 80 mcg/dl at 8 weeks of administration, the amount of zinc is increased to 100mg/day. Total administration period is 12 weeks.
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
Patients with hypozincemia and minimal encephalopathy due to liver cirrhosis, specifically patients who meet all the following conditions
1) Hypozincemia (<70mcg/dl)
2) Hyperammonemia (>50mcg/dl)
3) 2 or more abnormalities in Neuro-Psychological Tests
4) High signal of basal ganglia pallidus in T1-weighted image on head MRI
Key exclusion criteria
1) Overt hepatic encephalopathy of West Haven Criteria grade 2 or more
2) Child-Pugh C
3) Past history of overt hepatic encephalopathy
4) Past history of digestive tract bleeding within one year
5) Severe hypoalbuminemia (<2.8g/dl)
6) Chronic kidney disease (serum Creatinine value >2.0mg/dl)
7) With other causes that lead to cognitive decline or impaired consciousness (brain atrophy, cerebral infarction, intracranial lesions such as brain tumors, drug abuse or alcohol dependence, etc.)
8) Infectious diseases that require treatment with antibiotics
9) Progressive hepatocellular carcinoma (hepatocellular carcinoma with vascular infiltration or extrahepatic metastasis, liver cancer incapable of local treatment)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamoto |
Organization
Keio University, School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
1608582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
nobuhiro@z2.keio.jp
Public contact
Name of contact person
| 1st name | Nobuhito |
| Middle name | |
| Last name | Taniki |
Organization
Keio University, School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
1608582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
nobuhitotaniki@keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University, School of Medicine
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
Keio University, School of Medicine
Address
35 Shinanomachi Shinjuku-ku, Tokyo
Tel
+81-3-3353-1211
med-rinri-jimu@adst.keio.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
| 2019 | Year | 06 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2019 | Year | 06 | Month | 07 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042151
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