UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008197
Receipt number R000009663
Scientific Title Peg-IFN-alfa2a/Ribavirin combination therapy for chronic hepatitis C with serogroup1 and high viral load: analysis of IL28B gene and efficacy of vitamin D combination
Date of disclosure of the study information 2012/06/19
Last modified on 2014/01/07 06:50:39

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Basic information

Public title

Peg-IFN-alfa2a/Ribavirin combination therapy for chronic hepatitis C with serogroup1 and high viral load: analysis of IL28B gene and efficacy of vitamin D combination

Acronym

Peg-IFN-alfa2a/Ribavirin combination therapy with/without vitamin D for chronic hepatitis C with serogroup1 and high viral load

Scientific Title

Peg-IFN-alfa2a/Ribavirin combination therapy for chronic hepatitis C with serogroup1 and high viral load: analysis of IL28B gene and efficacy of vitamin D combination

Scientific Title:Acronym

Peg-IFN-alfa2a/Ribavirin combination therapy with/without vitamin D for chronic hepatitis C with serogroup1 and high viral load

Region

Japan


Condition

Condition

chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Efficacy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine Gene

Interventions/Control_1

IL-28B Gene major: Peg-IFN-alfa2a/Ribavirin

Interventions/Control_2

IL-28B Gene major: Peg-IFN-alfa2a/Ribavirin/VitaminD

Interventions/Control_3

IL-28B Gene minor: Peg-IFN-alfa2a/Ribavirin/VitaminD

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

chronic hepatitis C
serogroup1 and high viral load

Key exclusion criteria

contraindication of Peg-IFN/Ribavirin therapy

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuichi Kaneko

Organization

Kanazawa university

Division name

Graduate school of medicine

Zip code


Address

13-1 Takara-Machi, Kanazawa, Ishikawa, Japan

TEL

076-265-2235

Email

shimakami@m-kanazawa.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuro Shimakami

Organization

Kanazawa university

Division name

University hospital

Zip code


Address

13-1,Takaramachi, Kanazawa

TEL

076-265-2235

Homepage URL


Email

shimakami@m-kanazawa.jp


Sponsor or person

Institute

Kanazawa university

Institute

Department

Personal name



Funding Source

Organization

Kanazawa university

Organization

Division

Category of Funding Organization

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 06 Month 19 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

2011 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 01 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



Management information

Registered date

2012 Year 06 Month 19 Day

Last modified on

2014 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009663


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name