UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on Predictors of Treatment Response to Simeprevir, Peg-interferon and Ribavirin combination therapyin Patients with genotype Chronic Hepatitis C Virus Infection
Title of the study (Brief title)	Predictors of treatment response to SMV/Peg-IFN/RBV therapy
Region	Japan

Condition
Condition	Patients with genotype 1 HCV infection
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of simeprevir, Peg-IFN and Ribavirin combination therapy in patients with a chronic HCV genotype 1 infection, and investigate predictors of treatment response based on the analyses of viral and host factors
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the predictors obtained at baseline and affecting the sustained virologic response (SVR) rate/occurrence of adverse drug reactions at follow-up Week 12
Key secondary outcomes	Effects of HCV NS3/4 mutations as viral factors on virologic response 2) Rate of emergence of drug-resistant variants 3) Presence or absence of a reversal of liver fibrosis 4) Presence or absence of an improvement in AFP levels 5) Effects of glucose/lipid-related factors on treatment response 6) Incidence of AEs

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study. (1) Subjects Patients with a chronic HCV infection and compensated cirrhosis who are being treated as outpatients or inpatients at institutions participating in this study (2) Inclusion criteria [1] Patients who are 20 years of age or older at the time of informed consent [2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation [3] Patients with a chronic HCV genotype 1 infection and compensated cirrhosis who do not meet any of the following exclusion criteria
Key exclusion criteria	1) Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia) 2) Patients with severe hepatic impairment 3) Patients with a history of hypersensitivity to HCV protease inhibitors or Ribavirin 4) Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment 5) Patients deemed unsuitable for study entry by their treating physician 6) Patients with severe renal dysfunction 7) Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
Target sample size	200

Research contact person
Name of lead principal investigator	Goki Suda
Organization	Hokkaido University
Division name	Department of Gastroenterology and Hepatology, Graduate School of Medicine
Address	Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL	+81-11-716-1161
Email	gsudgast@pop.med.hokudai.ac.jp

Public contact
Name of contact person	Goki Suda
Organization	Hokkaido University
Division name	Department of Gastroenterology and Hepatology, Graduate School of Medicine
Address	Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL	+81-11-716-1161
Homepage URL
Email	gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Hokkaido University
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	2015 Year 12 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 09 Day
Anticipated trial start date	2013 Year 08 Month 09 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	This study is cohort study Way for subscription Patients who visit our hospital between August 2013 and march 2016, and meet inclusion criteria are enrolled.

Management information
Registered date	2015 Year 12 Month 21 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023438