UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003866 |
|---|---|
| Receipt number | R000004651 |
| Scientific Title | Analysis of factors predicting outcome of peginterferon plus ribavirin combination therapy for chronic hepatitis C-comparison between NK cell activity and other possible predictors |
| Date of disclosure of the study information | 2010/08/01 |
| Last modified on | 2025/01/13 10:47:51 |
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Basic information
Public title
Analysis of factors predicting outcome of peginterferon plus ribavirin combination therapy for chronic hepatitis C-comparison between NK cell activity and other possible predictors
Acronym
NK cell activity in IFN therapy for chronic hepatitis C
Scientific Title
Analysis of factors predicting outcome of peginterferon plus ribavirin combination therapy for chronic hepatitis C-comparison between NK cell activity and other possible predictors
Scientific Title:Acronym
NK cell activity in IFN therapy for chronic hepatitis C
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate NK cell activity as a predictor of antiviral outcome comparing with HCV core mutation, NS5A mutation and IL28B SNP
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Involvement of pretreatment NK cell activity with sustained virological response and non-response
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
genotype 1b and high viral load (greater than 5.0LogIU/mL)
Key exclusion criteria
liver cirrhosis
autoimmune hepatitis
primary biliary cirrhosis
malignancy
depression
drug abuse
pregnant or lactating woman
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Haruna |
Organization
Osaka Prefectural General Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka 558-8558
TEL
06-6692-1201
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka Prefectural General Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
apple-123-grape@ab.auone-net.jp
Sponsor or person
Institute
Osaka Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefectural General Medical Center
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
大阪府立急性期・総合医療センタ－（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 10 | Day |
Other
Other related information
To clarify involvement of pretreatment NK cell activity with antiviral response during the therapy as well as with sustained virological respose and non-response
Management information
Registered date
| 2010 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004651
