UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of liver fibrosis by acoustic radiation force impulse (ARFI) in hemodialysis patients with chronic hepatitis C
Title of the study (Brief title)	The accuracy of ARFI in assessing liver fibrosis of hemodialysis patients with chronic hepatitis C
Region	Japan

Condition
Condition	chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is assessment of the usefulness of acoustic radiation force impulse (ARFI) in evaluation of liver fibrosis in hemodialysis patients with chronic hepatitis C (CH-C). First, assessment of the evaluation of liver fibrosis is compared between histological diagnosis by liver biopsy and ARFI value in hemodialysis patients with CH-C. Second, regular examination of liver fibrosis is conducted by ARFI and liver fibrosis marker. Next, among patients without anti-viral therapy, progression rate of liver fibrosis and cumulative incidence of HCC are compared between CH-C patients with or without hemodialysis. Among patients with anti-viral therapy, the regression rate of liver fibrosis as anti-viral effect is compared between CH-C patients with or without hemodialysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- The accuracy of ARFI for evaluation of liver fibrosis in hemodialysis patients with chronic hepatitis C - Comparison of the degree of liver fibrosis between hemodialysis patients with CH-C, non-hemodialysis patients with CH-C and hemodialysis patients without HCV infection - Comparison for progression rate of fibrosis by ARFI between CH-C patients with or without hemodialysis - Comparison for cumulative incidence of HCC by ARFI between CH-C patients with or without hemodialysis - Investigating sustained virological response rate (the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment) of Peg-IFN alpha mono-therapy in CH-C patients with hemodialysis - Comparison of regression rate of liver fibrosis and suppressive effect on HCC incidence of Peg-IFN alpha mono-therapy in CH-C patients with hemodialysis between CH-C patients with or without HD and HD patients without HCV infection
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- Hemodialysis patients with chronic hepatitis C (HCV antibody positive, HCV-RNA positive) - Non-hemodialysis patients with chronic hepatitis C (HCV antibody positive, HCV-RNA positive) - Hemodialysis patients without HCV (HCV antibody negative)
Key exclusion criteria	1) Patients under 20 years old 2) Patients with co-infection with hepatitis B virus 3) Patients with co-infection with human immunodeficiency virus 4) Patients with alcoholic liver disorder or autoimmune hepatitis 5) Patients with uncompensated cirrhosis or hepatic failure 6) Patients with multiple organ failure or immunological deficiency 7) Patients with severe depression or past history of psychiatric disorder 8) Patients in pregnancy or lactating or patients who expect to become pregnant 9) Patients whose hemoglobin levels are less than 8.5g/dL 10) Patients whose platelet counts are less than 25,000/microL 11) Patients whose neutrophil counts are less than 500 /microL 12) Patients whom investigator disqualified
Target sample size	160

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka Suita Osaka Japan
TEL	06-6879-5111
Email	yuki.tahata@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Yuki Tahata
Organization	2-2 Yamadaoka Suita Osaka Japan
Division name	Gastroenterology and Hepatology
Address	2-2 Yamadaoka Suita Osaka Japan
TEL	06-6879-5111
Homepage URL
Email	yuki.tahata@gh.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Osaka University Graduate 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)

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	2013 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 19 Day
Anticipated trial start date	2013 Year 06 Month 19 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	- Among CH-C patients with or without hemodialysis CH-C who meet the selection criteria, liver biopsy, ARFI, fibrosis markers and imaging test are performed at the start of observation in order to evaluate the degree of liver fibrosis. Among hemodialysis patients without HCV infection, ARFI, fibrosis markers and imaging test are performed (Liver biopsy is not performed). - CH-C patients with Hemodialysis are treated with pegylated interferon alpa 2a mono-therapy. CHC-patients without hemodialysis are treated with usual anti-viral therapy. - Evaluation of the degree of liver fibrosis by ARFI and liver fibrosis markers is performed every 6 months after first evaluation. Surveillance of HCC are also performed at the same time.

Management information
Registered date	2013 Year 07 Month 22 Day
Last modified on	2018 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013183