UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037194
Receipt No. R000042401
Scientific Title The analysis of pathological change in liver after eradication of Hepatitis C virus.
Date of disclosure of the study information 2019/06/27
Last modified on 2019/06/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The analysis of pathological change in liver after eradication of Hepatitis C virus.
Acronym The analysis of pathological change in liver after eradication of Hepatitis C virus.
Scientific Title The analysis of pathological change in liver after eradication of Hepatitis C virus.
Scientific Title:Acronym The analysis of pathological change in liver after eradication of Hepatitis C virus.
Region
Japan

Condition
Condition liver cirrosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the aim of this study is to clarify the pathological change in liver after eradication of HCV.
Basic objectives2 Others
Basic objectives -Others the overall survival rate after SVR
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes the liver function and pathological status after eradication of HCV.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients who obtained SVR by DAA therapy.
the patients who under who underwent CT imaging at pretreatment, SVR, and 48 weeks after SVR.
Key exclusion criteria the patients with any other liver diseases, including autoimmune hepatitis, drug-induced liver disease, and primary biliary cholangitis. Patients with Child-Pugh class B and C cirrhosis or who developed hepatocellular carcinoma during this study period were excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name seko
Middle name
Last name yuya
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code 6028566
Address 465 kajiityou, kamigyo-ku, kyoto
TEL 0752515519
Email yuyaseko@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name seko
Middle name
Last name yuya
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code 6028566
Address 465 kajiityou, kamigyo-ku, kyoto
TEL 0752515519
Homepage URL
Email yuyaseko@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University 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 Kyoto Prefectural University of Medicine
Address 465 kajiityou, kamigyo-ku, kyoto
Tel 0752515519
Email yuyaseko@koto.kpu-m.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 27 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
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 01 Month 12 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information we investigated the relationship between liver volume and the changes in platelet counts of Japanese patients with HCV infection treated with DAAs who obtained SVR.

Management information
Registered date
2019 Year 06 Month 27 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042401

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.