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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002580
Receipt No. R000003145
Scientific Title Prospective validation for the usefulness of Genome-wide association study (GWAS) in predicting the effects of anti-viral therapy on chronic hepatitis C
Date of disclosure of the study information 2009/10/08
Last modified on 2009/10/03

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Basic information
Public title Prospective validation for the usefulness of Genome-wide association study (GWAS) in predicting the effects of anti-viral therapy on chronic hepatitis C
Acronym Chronic hepatitis C and GWAS
Scientific Title Prospective validation for the usefulness of Genome-wide association study (GWAS) in predicting the effects of anti-viral therapy on chronic hepatitis C
Scientific Title:Acronym Chronic hepatitis C and GWAS
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 evaluate predictability of therapeutic outcome by prospectively measuring SNPs, which were recently identified by coworkers, in patients with chronic hepatitis C treated by peginterferon/ribavirin combination therapy
Basic objectives2 Others
Basic objectives -Others Relationship between targeted SNPs and virological response to peginterferon/ribavirin combination therapy
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between targeted SNPs and virological response to peginterferon/ribavirin combination therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Peginterferon alpha2a or alpha2b plus ribavirin for 48-72 weeks
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 of genotype 1 and high viral load who newly start peginterferon and ribavirin combination therapy
Key exclusion criteria 1) Patients taking Sho-sai-koto(herbal medicine)
2) Autoimmune hepatitis
3) Patients with history of interstitial pneumonia
4) Patients with previous history of drug allergy against ribavirin, peginterferon alpha2a (Pegasys), peginterferon alpha2b (Pegintron), or other interferons
5) Patients with previous history of drug allergy against biological products such as vaccines
6) Liver cirrhosis, liver failure or hepatocellular carcinoma
7) Patients with the following laboratory data at the start of peginterferon and ribavirin combination therapy: WBC counts less than 4,000/microliter and Neutrophil counts less than 1,500/microliter; Platelets counts less than 90,000/microliter (peginterferon alpha2a) or 100,000/microliter(peginterferon alpha2b); Hemoglobin levelsless than 12g/dL
8) Women who are pregnant or have its possibility
9) Patients who refuse birth control, including male patients whose patners may have the chance to be pregnant
10) Patients whom the physicians in charge judge their enrollment inappropriate
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohiko Masaki, M.D.
Organization Kohnodai Hospital, International Medical Center of Japan
Division name Research Center for Hepatitis & Immunology
Zip code
Address 1-7-1 Kohnodai, Ichikawa, Chiba 272-8516, JAPAN
TEL 81-47-372-3501
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naohiko Masaki, M.D.
Organization Kohnodai Hospital, International Medical Center of Japan
Division name Research Center for Hepatitis & Immunology
Zip code
Address 1-7-1 Kohnodai, Ichikawa, Chiba 272-8516, JAPAN
TEL 81-47-372-3501
Homepage URL
Email nmasaki@imcjk2.hosp.go.jp

Sponsor
Institute Research Center for Hepatitis & Immunology, Kohnodai Hospital, International Medical Center of Japan
Institute
Department

Funding Source
Organization International Medical Center of Japan
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 国立国際医療センター戸山病院(東京都)、国立国際医療センター国府台病院(千葉県)、東京大学病院(東京都)、国立病院機構長崎医療センター(長崎県)、武蔵野赤十字病院(東京都)、名古屋市立大学病院(愛知県)、兵庫医科大学病院(兵庫県)、川崎医科大学病院(岡山県)、順天堂大学病院(東京都)、新潟大学病院(新潟県)、山梨大学病院(山梨県)、愛知医科大学病院(愛知県)、国立病院機構大阪医療センター(大阪府)、国立病院機構高崎病院(群馬県)、社会保険中央総合病院(東京都)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 08 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 Enrolling by invitation
Date of protocol fixation
2009 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 03 Day
Last modified on
2009 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003145

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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