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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005502
Receipt No. R000006110
Scientific Title IL28B gene polymorphism analysis and clinical research (effectiveness prediction of interferon treatment)
Date of disclosure of the study information 2011/04/25
Last modified on 2018/09/20

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Basic information
Public title IL28B gene polymorphism
analysis and clinical research (effectiveness prediction of interferon treatment)
Acronym IL28B gene polymorphism
analysis and clinical research
Scientific Title IL28B gene polymorphism
analysis and clinical research (effectiveness prediction of interferon treatment)
Scientific Title:Acronym IL28B gene polymorphism
analysis and clinical research
Region
Japan

Condition
Condition Chronic hepatitis c
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 When the Peginterferon plus ribavirin treatment to chronic hepatitis c patients, IL28B gene polymorphism is measured and the expected therapeutic gain is examined.
Basic objectives2 Others
Basic objectives -Others Relationship between host factors and virological response to Peginterferon plus ribavirin treatment
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between IL28B gene polymorphism and virological response to Peginterferon plus ribavirin treatment
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 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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The following chronic hepatitis C patients with serogroup 1 and high viral load were eligible to enter the trial
1) From 18 years old or over
2)Chronic hepatitis C
3)The presence of the liver biopsy is not asked
4)HCV RNA>=5LogIU/mL
5)Platelet count >=90,000/micro L
6)WBC count>=3,000/micro L.
Neutrophil count >=1,500/micro L.
Hemoglobin concentration >=12g/dL.
7)The presence of the IFN treatment history is not asked
8)Patients who provided written informed consents to participate the study prior to enrollment
Key exclusion criteria The following patients were excluded
1)Women of childbearing potential and pregnancy, lactating woman
2) allergic to ribavirin or nucleoside analogues
3)an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia)
4)hemoglobinopathy(thalassemia, sickle cell disease)
5) severe renal disease, Ccr <50ml/min
6) severe depression or psychosomatic disorders
7)severe liver disease
8) autoimmune hepatitis or HBV
9) drug allergy against interferon
10) Allergic to vaccine or biological preparations
11) Concomitant herbal medication of Sho-saikoto
12) history of interstitial pneumonia
13)Other conditions considered inappropriate by attending physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouji Yakabi
Organization Saitama Medical Center
Division name Division of Gastroenterology and Hepatology,internal Medicine
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 049-228-3400
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kouji Yakabi
Organization Saitama Medical Center
Division name Division of Gastroenterology and Hepatology,internal Medicine
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Saitama Medical Center
Institute
Department

Funding Source
Organization None
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
2011 Year 04 Month 25 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 Completed
Date of protocol fixation
2011 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 05 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
2011 Year 04 Month 25 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006110

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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