UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011248 |
|---|---|
| Receipt number | R000013183 |
| Scientific Title | The evaluation of liver fibrosis by acoustic radiation force impulse (ARFI) in hemodialysis patients with chronic hepatitis C |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2018/01/24 16:36:56 |
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Basic information
Public title
The evaluation of liver fibrosis by acoustic radiation force impulse (ARFI) in hemodialysis patients with chronic hepatitis C
Acronym
The accuracy of ARFI in assessing liver fibrosis of hemodialysis patients with chronic hepatitis C
Scientific Title
The evaluation of liver fibrosis by acoustic radiation force impulse (ARFI) in hemodialysis patients with chronic hepatitis C
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tetsuo Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka Suita Osaka Japan
TEL
06-6879-5111
yuki.tahata@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Tahata |
Organization
2-2 Yamadaoka Suita Osaka Japan
Division name
Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka Suita Osaka Japan
TEL
06-6879-5111
Homepage URL
yuki.tahata@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 19 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013183
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