UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	IL28B gene polymorphism analysis and clinical research (effectiveness prediction of interferon treatment)
Title of the study (Brief title)	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	Kouji Yakabi
Organization	Saitama Medical Center
Division name	Division of Gastroenterology and Hepatology,internal Medicine
Address	1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL	049-228-3400
Email

Public contact
Name of contact person	Kouji Yakabi
Organization	Saitama Medical Center
Division name	Division of Gastroenterology and Hepatology,internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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