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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019212
Receipt No. R000022195
Scientific Title Clinical Trial of 12 weeks of oral DAA therapy for HCV Genotype 1-infected Japanese Patients
Date of disclosure of the study information 2015/10/02
Last modified on 2015/10/02

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Basic information
Public title Clinical Trial of 12 weeks of oral DAA therapy for HCV Genotype 1-infected Japanese Patients
Acronym 12ODTG1
Scientific Title Clinical Trial of 12 weeks of oral DAA therapy for HCV Genotype 1-infected Japanese Patients
Scientific Title:Acronym 12ODTG1
Region
Japan

Condition
Condition Chronic hepatitis C (genotype 1)
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety
Basic objectives2 Others
Basic objectives -Others metabolic markers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained virological 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria HCV genotype 1 patients
Chronic hepatitis or compensated liver cirrhosis
Patients with viremia
Key exclusion criteria Patients who have allergy to DAAs
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Sato
Organization Gunma University
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL 027-220-8127
Email satoken@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Sato
Organization Gunma University
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL 027-220-8127
Homepage URL
Email satoken@gunma-u.ac.jp

Sponsor
Institute Gunma University and affiliated hospitals
Institute
Department

Funding Source
Organization Gunma University
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
2015 Year 10 Month 02 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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study
sampling method
registration of patients in Gunma
University hospital and its affiliated hospitals
research design
prospective cohort
exposure factor to be measured
antiviral effect
confounding factor to be adjusted
To minimize the dropouts and recruit a wide age group as much as possible

Management information
Registered date
2015 Year 10 Month 02 Day
Last modified on
2015 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022195

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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