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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002326
Receipt No. R000002645
Scientific Title Relation between immuno-reacton and effectiveness of DFPP among the chronic hepatitis C patients with PEG-IFN and RBV combination therapy.
Date of disclosure of the study information 2009/08/20
Last modified on 2012/02/28

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Basic information
Public title Relation between immuno-reacton and effectiveness of DFPP among the chronic hepatitis C patients with PEG-IFN and RBV combination therapy.
Acronym Immuno-reaction and effectiveness of DFPP therapy
Scientific Title Relation between immuno-reacton and effectiveness of DFPP among the chronic hepatitis C patients with PEG-IFN and RBV combination therapy.
Scientific Title:Acronym Immuno-reaction and effectiveness of DFPP therapy
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 to analyze the immunological parameter before and after DFPP therapy.
Basic objectives2 Others
Basic objectives -Others The aim of this study is to analyze the immunological parameter before and after DFPP therapy.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes We evalulate the immunological parameter before and after DFPP therapy.
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 Chornic hepatitis C patients who can recive PEG-IFN, RBV and DFPP combination therapy
Key exclusion criteria The existence of the other type of liver diseases.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tooru Shimosegawa
Organization Tohoku University Hospital
Division name Gastroenterology
Zip code
Address 1-1Seiryo-machi, Aoba-ku, Sendai City, Miyagi, Japan
TEL 022-717-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuteru Kondo
Organization Tohoku University Hospital
Division name Gastroenterology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai City, Japajn
TEL 022-717-7171
Homepage URL
Email yasuteru@ebony.plala.or.jp

Sponsor
Institute Department of Gastroenterology, Tohoku University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology, Tohoku University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
All patients (4/4) treated with the major IL28B allele (T/T) could achieve complete early virological response (EVR). The amounts of HCV-Core antigen in the peripheral blood of EVR patients treated with DFPP/Peg-IFN/RBV rapidly declined in comparison to those of late virological response (LVR) patients treated with DFPP/Peg-IFN/RBV and EVR patients treated with Peg-IFN and RBV (Peg-IFN/RBV). The amount of IFN-g produced from peripheral blood gradually increased. On the other hand, the amount of IL10 gradually decreased in the EVR patients. The frequencies of HCV-Core binding on CD3+ T cells rapidly declined in EVR patients treated with DFPP/Peg-IFN/RBV therapy. Moreover, the distributions of activated CD4(+) and CD8(+) T cells and CD16-CD56 high natural killer cells were significantly changed between before and after DFPP.
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
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information Collecting the subjects who can enter this analysis.

Management information
Registered date
2009 Year 08 Month 12 Day
Last modified on
2012 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002645

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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