UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Response-Guided Interferon Therapy for patients with chronic hepatitis C of the Genotype 1 high viral load: Japanese multi-center, randomized controlled study: (ReGIT-J study)
Title of the study (Brief title)	Response-Guided Interferon Therapy for patients with chronic hepatitis C : Japanese multi-center, randomized controlled study: (ReGIT-J study)
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examined treatment method and duration from the HCV-RNA negativity time in an PEG-IFN alfa-2 a/RBV combination therapy or a PEG-IFNalfa-2a/RBV combination therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Virological response:SVR HCVRNA negativity of 24 weeks of end of treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	8
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	PEG-IFN alfa-2a monotherapy in the patients who undetectable HCV-RNA at week 4
Interventions/Control_2	PEG-IFNalfa-2a/Ribavirin combination therapy in the patients who undetectable HCV-RNA at week 4
Interventions/Control_3	PEG-IFN alfa-2a once a week/ Ribavirin combination therapy in the patients who detectable HCV-RNA at week 4 but undetectable HCV-RNA at week 12
Interventions/Control_4	PEG-IFN alfa-2a biweekly/Ribavirin combination therapy in the patients who detectable HCV-RNA at week 4 but undetectable HCV-RNA at week 12
Interventions/Control_5	PEG-IFNalfa-2a/Ribavirin combination therapy in the patients who detectable HCV-RNA at week 12 but undetectable HCV-RNA at week 24
Interventions/Control_6	PEG-IFNalfa-2a/Ribavirin/Fluvastatin combination therapy in the patients who detectable HCV-RNA at week 12 but undetectable HCV-RNA at week 24
Interventions/Control_7	PEG-IFN alfa-2a half dose long term maintenance therapy in the patients who detectable HCV-RNA at week 24
Interventions/Control_8	A treatment cancellation follow-up in the patients who detectable HCV-RNA at week 24
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Existence of previous treatment (interferon therapy including a Ribavirin combined therapy) is not asked. 2.Genotype1,more than HCV-RNA 100KIU/ml 3.Baseline of the following clinical laboratory test result / before a medication start -- the patient who filled all WBC count : more than3,000/mm3 neutrophil count: more than 1,500/mm3 PLT count:more than 90,000/mm3 Hemoglobin content :more than12g/dl 4.The patient by sufficient understanding top after being given ( sufficient ) in participation of an exam, and a document -- the patient by whom the consent by the free intention of the person himself/herself was got
Key exclusion criteria	1.A pregnant woman, the woman who may have become pregnant, or the woman under breastfeeding 2.The patient who has an anamnesis of hypersensitivity to the ingredient or other nucleoside analogs of this agent (acyclovir, ganciclovir, Bidarabin, etc.) 3.A patient with cardiac disease (myocardial infarction, heart failure, abnormal heart rhythm etc.) with difficult control 4.The patient of abnormal hemoglobin diseases (sarasemia, drepanocytic anemia, etc.) 5.The patient to whom the following renal dysfunction has chronic renal failure or a creatinine clearance by 50mL/min 6.A patient with the patient in serious mental disease states, such as serious depression, suicide ideation, or a suicide attempt, or its anamnesis 7.A critical impaired liver function patient 8.The patient of autoimmune hepatitis 9.The patient who is prescribing Syousaikotou 10.The chronic liver disease patient of others, such as autoimmune hepatitis and alcoholic hepatitis 11.The patient who has an anamnesis of hypersensitivity to the ingredient or other interferon tablets of this agent 12.The patient who has an anamnesis of hypersensitivity to biological preparation, such as a vaccine 13.The patient of liver cirrhosis, hepatic insufficiency, and cancer of liver 14.The patient who meets at least one standard of the following clinical laboratory test result / before a medication start before treatment WBC count Less than 3,000/mm3 neutrophil count Less than 1,500/mm3 PLT count Less than 90,000/mm3 Hemoglobin content Less than 12g/dl 15.In addition, the patient whom the examination doctor in attendance judged that the participation to an exam is unsuitable
Target sample size	300

Research contact person
Name of lead principal investigator	Shuhei Nishiguchi
Organization	Hyogo College Of Medicine
Division name	Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Address	1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL	0798-45-6472
Email

Public contact
Name of contact person	Teruhisa Yamamoto
Organization	Hyogo College Of Medicine
Division name	Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Address	1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL	0798-45-6472
Homepage URL
Email

Sponsor
Institute	Hyogo College Of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	None

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	石切生喜病院（大阪府）、大阪医科大学（大阪府）、大阪赤十字病院（大阪府）、 関西医科大学附属枚方病院（大阪府）、関西医科大学附属滝井病院（大阪府）、 近畿大学（大阪府）、神戸朝日病院（兵庫県）、新生病院（大阪府）、摂津ひかり病院（大阪府）、 大正病院（大阪府）、田辺中央病院（大阪府）、兵庫医科大学（兵庫県）、枚方市民病院（大阪府）、 北摂総合病院（大阪府）、牧病院（大阪府）、守口敬仁会病院（大阪府）、 わかこうかい病院（大阪府）

Other administrative information
Date of disclosure of the study information	2009 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 05 Month 01 Day
Anticipated trial start date	2007 Year 05 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 11 Month 11 Day
Last modified on	2016 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003242