UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018947
Receipt number R000021917
Scientific Title A Study on Predictors of Treatment Response to Sofosbuvir and Ribavirin Therapy in Patients with genotype 2 Chronic Hepatitis C Virus Infection
Date of disclosure of the study information 2015/09/08
Last modified on 2022/10/06 10:06:59

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Basic information

Public title

A Study on Predictors of Treatment Response to Sofosbuvir and Ribavirin Therapy in Patients with genotype 2 Chronic Hepatitis C Virus Infection

Acronym

Predictor of treatment response to SOF /RBV therapy

Scientific Title

A Study on Predictors of Treatment Response to Sofosbuvir and Ribavirin Therapy in Patients with genotype 2 Chronic Hepatitis C Virus Infection

Scientific Title:Acronym

Predictor of treatment response to SOF /RBV therapy

Region

Japan


Condition

Condition

Patients with genotype 2 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 sofosbuvir plus ribavirin therapy in patients with a chronic HCV genotype 2 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 NS5B 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 2 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 NS5B 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

Target sample size

260


Research contact person

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


Public contact

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


Sponsor or person

Institute

Hokkaido University Department of Gastroenterology and Hepatology, Graduate School of Medicine,

Institute

Department

Personal name



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

2015 Year 09 Month 08 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

2015 Year 05 Month 12 Day

Date of IRB

2015 Year 06 Month 16 Day

Anticipated trial start date

2015 Year 09 Month 08 Day

Last follow-up date

2019 Year 04 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is cohort study
Way for subscription
Patients who visit our hospital between June 2015 and march 2018, and meet inclusion criteria are enrolled.
We will check below
1 Viral factors: HCV NS5A/NS3 inhibitor resistant mutations
2 Peripheral blood tests: WBC, differential WBC, Hb, and Plt
3 Liver function tests AST, ALT, GTP, and ALP
4 Biochemistry LDH, BUN, total bilirubin, direct bilirubin, ALP, GTP, total protein, albumin, creatinine, Na, K, Cl, amylase, and lipase
5 Fibrosis markers: hyaluronic acid, type IV collagen etc, and AFP
6 Glucose tolerance tests: fasting glucose, insulin, and HbA1c Lipid metabolism: TC, LDL-C, and TG; Blood coagulation
7 Viral kinetics: serial measurement of viral titer
8 Measurement of liver stiffness by liver biopsy/FibroScan


Management information

Registered date

2015 Year 09 Month 08 Day

Last modified on

2022 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021917


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name