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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003976
Receipt No. R000004793
Scientific Title Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
Date of disclosure of the study information 2010/08/01
Last modified on 2016/06/09

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Basic information
Public title Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
Acronym Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
Scientific Title Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
Scientific Title:Acronym Prospective and Retrospective Multicenter Cohort Study of Patients With Chronic Hepatitis C Treated by Peginterferon Alfa-2b Plus Ribavirin
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 elucidate factors contributing sustained viral response of Peginterferon alfa-2b plus Ribavirin treatment in patients with chronic hepatitis C
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Sustained virological response 24 weeks after the end of treatment
Key secondary outcomes Safety

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 Patients with chronic hepatitis C whose HCV-RNA is >= 5.0 logIU/mL or null responder or relapser to interferon monotherapy.
Key exclusion criteria Any contraindication to peginterferon alfa-2b + ribavirin therapy
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Koike
Organization The University of Tokyo Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5689-4016
Email tateishi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Tateishi
Organization The University of Tokyo Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email tateishi-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology
The University of Tokyo Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology, the University of Tokyo 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
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
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 No longer recruiting
Date of protocol fixation
2010 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients background including sex, age, body height, body weight, BMI, medical comorbidity, previous treatment for chronic hepatitis C, liver biopsy, laboratory data, adverse events and virological response after treatment.

Management information
Registered date
2010 Year 08 Month 01 Day
Last modified on
2016 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004793

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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