UMIN-CTR Clinical Trial

Public title

A Study on Predictors of Treatment Response to Simeprevir, Peg-interferon and Ribavirin combination therapyin Patients with genotype Chronic Hepatitis C Virus Infection

Acronym

Predictors of treatment response to SMV/Peg-IFN/RBV therapy

Scientific Title

A Study on Predictors of Treatment Response to Simeprevir, Peg-interferon and Ribavirin combination therapyin Patients with genotype Chronic Hepatitis C Virus Infection

Scientific Title:Acronym

Predictors of treatment response to SMV/Peg-IFN/RBV therapy

Region

Japan

Condition

Patients with genotype 1 HCV infection

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Goki Suda

Organization

Hokkaido University

Division name

Department of Gastroenterology and Hepatology, Graduate School of Medicine

Zip code

Address

Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid

TEL

+81-11-716-1161

Email

gsudgast@pop.med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Goki Suda

Organization

Hokkaido University

Division name

Department of Gastroenterology and Hepatology, Graduate School of Medicine

Zip code

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

Institute

Hokkaido University

Institute

Department

Personal name

Organization

Hokkaido University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

08

Month

09

Day

Date of IRB

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

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.

Registered date

2015

Year

12

Month

21

Day

Last modified on

2019

Year

02

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023438