UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025191
Receipt number R000028979
Scientific Title Prospective study of Grazoprevir and Elbasvir for HCV genotype 1 intected Japanese patients
Date of disclosure of the study information 2017/01/15
Last modified on 2022/06/14 23:27:12

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Basic information

Public title

Prospective study of Grazoprevir and Elbasvir for HCV genotype 1 intected Japanese patients

Acronym

IFN free GE study

Scientific Title

Prospective study of Grazoprevir and Elbasvir for HCV genotype 1 intected Japanese patients

Scientific Title:Acronym

IFN free GE study

Region

Japan


Condition

Condition

HCV genotype 1 infected chronic liver
disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Efficacy and safety

Basic objectives2

Others

Basic objectives -Others

viral genome

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sustained viral response (12 weeks post-treatment)

Key secondary outcomes

Regression rate of liver fibrosis
Suppressive effect on HCC incidence


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


 Not applicable

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

HCV genotype 1 infected patients with chronic liver disease
Patients satisfied the public indication
for Grazoprevir and Elbasvir

Key exclusion criteria

Pregnant woman
Decompensated cirrhosis
hepatocellular carcinoma
Doctors judge as inappropriate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Tamori

Organization

Osaka City University Graduated School of medicine

Division name

Department of Hepatology

Zip code

545-8585

Address

1-4-3, Asahimachi, Abeno-ku, Osaka, Japan

TEL

06-6645-3905

Email

atamori@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Ritsuzo
Middle name
Last name Kozuka

Organization

Osaka City University Graduated School of medicine

Division name

Department of Hepatology

Zip code

545-8585

Address

1-4-3, Asahimachi, Abeno-ku, Osaka, Japan

TEL

06-6645-3905

Homepage URL


Email

m1159834@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University and affiliated
hospital

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

Ethics Committee of Osaka City University Hospital

Address

1-4-3, Asahimachi, Abeno-ku, Osaka, Japan

Tel

06-6645-3435

Email

ethics@med.osaka-cu.ac.jp


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

2017 Year 01 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

119

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

Main results already published

Date of protocol fixation

2016 Year 11 Month 28 Day

Date of IRB

2016 Year 11 Month 28 Day

Anticipated trial start date

2016 Year 12 Month 15 Day

Last follow-up date

2021 Year 11 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patietnts treated with Grazoprevir and Elbasvir from December 15 2016 to December 31 2020.
Examination of HCV viral load, ALT, Platelet, AFP, M2BPGi


Management information

Registered date

2016 Year 12 Month 08 Day

Last modified on

2022 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name