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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007400
Receipt No. R000008719
Scientific Title The efficacy and safety analysis of Peg-IFN/RBV/Vitamin D3 therapy for liver cirrhosis with hepatitis c persistent infection: RCT Study
Date of disclosure of the study information 2012/03/01
Last modified on 2013/06/11

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Basic information
Public title The efficacy and safety analysis of Peg-IFN/RBV/Vitamin D3 therapy for liver cirrhosis with hepatitis c persistent infection: RCT Study
Acronym LCVID STUDY
Scientific Title The efficacy and safety analysis of Peg-IFN/RBV/Vitamin D3 therapy for liver cirrhosis with hepatitis c persistent infection: RCT Study
Scientific Title:Acronym LCVID STUDY
Region
Japan

Condition
Condition Liver cirrhosis with hepatitis c persistent infection
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To analyze the efficacy of Peg-IFN/RBV/Vitamin D therapy
Basic objectives2 Others
Basic objectives -Others To analyze the immunological parameters during therapy.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes SVR rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Peg-IFN/RBV/Vitamin D3
Interventions/Control_2 Peg-IFN/RBV
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Over 20 years old
LC-C
WBC>3000
Neut>1500
PLT>75000
Hb>12

Key exclusion criteria Pregnant
Drug allergy
Hear Disease
Abnormal Hb
Renal Failure
Sever Liver Disease
Autoimmune Hepatitis etc.
Target sample size 60

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

Sponsor
Institute Division of Gastroenterology, Tohoku University Hospital
Institute
Department

Funding Source
Organization Divisino of Gastroenterology, Tohoku University Hospital
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
2012 Year 03 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 Open public recruiting
Date of protocol fixation
2012 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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 open

Management information
Registered date
2012 Year 02 Month 28 Day
Last modified on
2013 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008719

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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