UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030599
Receipt number R000034941
Scientific Title Prospective study of anti-HCV therapy with pan-genotype direct acting anti-viral agents for patients with chronic liver diseases
Date of disclosure of the study information 2018/01/31
Last modified on 2023/04/25 09:30:14

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Basic information

Public title

Prospective study of anti-HCV therapy with pan-genotype direct acting anti-viral agents for patients with chronic liver diseases

Acronym

Study of pan-genotype anti-HCV therapy

Scientific Title

Prospective study of anti-HCV therapy with pan-genotype direct acting anti-viral agents for patients with chronic liver diseases

Scientific Title:Acronym

Study of pan-genotype anti-HCV therapy

Region

Japan


Condition

Condition

Chronic liver disease type C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation for anti-viral effect and safety of pan-genotype DAA in patients with chronic liver disease type C

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sustained viral response at post-treatment 12-week (SVR12)

Key secondary outcomes

HCV RNA at end-of-treatment and at post-treatment 24-week (SVR24)
Liver function test after treatment
Adverse events


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 with chronic liver disease related HCV infection

Key exclusion criteria

1) Active malignant tumor including liver cancer
2) Decompensated hepatic cirrhosis
3) Prohibition of per oral drugs
4) Medication contraindication drugs to pan-genotype DAAs
5) Allergy to pan-genotype DAA
6) Unsuitable condition to the present study

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Tamori

Organization

Osaka City University

Division name

Department of Hepatology

Zip code

5458585

Address

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

TEL

06-6645-3905

Email

atamori@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Tamori

Organization

Osaka City University

Division name

Department of Hepatology

Zip code

5458585

Address

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

TEL

06-6645-3905

Homepage URL


Email

atamori@med.osaka-cu.ac.jp


Sponsor or person

Institute

Department of Hepatology, Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Hepatology, Osaka City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tokyo University, Yamaguchi University, Osaka University, Osaka Rosai Hospital, Okayama City General Medical Center, Okayama University, Tokushima University, Kagawa Prefectural Central Hospital, Kurume University, Tokai University, Chiba University, The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The ethical committee, Osaka City University Graduate School of Medicine

Address

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

Tel

06-6645-3456

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

東京大学医科学研究所先端医療研究センター感染症分野、山口大学臨床検査・腫瘍学講座、大阪大学機能診断科学、大阪労災病院消化器内科、岡山市立市民病院消化器内科、岡山大学保健管理センター、徳島大学消化器内科、香川県立中央病院肝臓内科、久留米大学超音波診断センター消化器内科、東海大学消化器内科、三重大学消化器内科、千葉大学消化器内科、国立国際医療研究センター肝炎・免疫センター


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 31 Day


Related information

URL releasing protocol

doi: 10.1111/hepr.13410

Publication of results

Partially published


Result

URL related to results and publications

doi: 10.1111/hepr.13410

Number of participants that the trial has enrolled

423

Results

Glecaprevir + pibrentasvir had a remarkable anti-HCV effect in GT-1 and GT-2 patients, but not in GT-3b patients.
Although this therapy was reasonably safe, it is necessary to carefully consider elderly and dropout patients.

Results date posted

2022 Year 07 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 12 Month 01 Day

Baseline Characteristics

A total of 423 patients infected with HCV who started treatment at eight different centers in Japan were enrolled in thestudy.

Participant flow

Prospective study

Adverse events

Four of seven patients who discontinued treatment due to severe adverse effects were more than 75 years old.

Outcome measures

Glecaprevir + pibrentasvir had a remarkable anti-HCV effect in GT-1 and GT-2 patients, but not in GT-3b patients.

Plan to share IPD

No plan

IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 30 Day

Date of IRB

2017 Year 12 Month 22 Day

Anticipated trial start date

2017 Year 12 Month 22 Day

Last follow-up date

2022 Year 01 Month 21 Day

Date of closure to data entry

2022 Year 01 Month 21 Day

Date trial data considered complete

2022 Year 01 Month 21 Day

Date analysis concluded

2022 Year 12 Month 31 Day


Other

Other related information

Past history of anti-HCV therapy, and HCC therapy.
Progression of hepatic cirrhosis, HCV genotype.
At baseline; HCV RNA, Plt, AST, ALT, Alb, T. Bil, PT, AFP, Cre, BUN, M2BPGi, type-IV collagen.
End of treatment and after treatment 12-week and 24-week; HCV RNA, Plt, AST, ALT, Alb, T. Bil, PT, AFP, M2BPGi.


Management information

Registered date

2017 Year 12 Month 27 Day

Last modified on

2023 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name