UMIN-CTR Clinical Trial

Public title

Retrospective cohort study of resistance associated substitutions and clinical course in Glecaprevir(GLE)/Pibrentasvir(PIB) treatment to hepatitis C virus

Acronym

RASs and clinical course in GLE/PIB treatment

Scientific Title

Retrospective cohort study of resistance associated substitutions and clinical course in Glecaprevir(GLE)/Pibrentasvir(PIB) treatment to hepatitis C virus

Scientific Title:Acronym

RASs and clinical course in GLE/PIB treatment

Region

Japan

Condition

Hepatitis C virus infected patients

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Direct-acting antiviral agents (DAAs) which specifically effect for HCV virus were recently developed. The first generation treatment of Daclatasvir(DCV) /Asunaprevir(ASV) were available from 2014 in Japan for genotype 1. From sep. 2015, Sofosbuvir / ledipasvir were available. After that, Ombitasvir/Paritaprevir/ritonavir, Elbasvir/Grazoprevir were available. Sofosbuvir / Ribavirin were available for genotype 2 from June 2016. Ombitasvir/Paritaprevir/ritonavir/Ribavirin were available subsuquently. Resistance associated substitutions (RASs) were deeply associated with virologically non response and viral breakthrough. RASs affected DCV/ASV treatment outcome.
Glecaprevir/Pibrentasvir, which is for pan-genotype, will be available from Nov. 2017. RASs is expected to influence the outcome of Glecaprevir/Pibrentasvir treatments.
We evaluate the RASs and clinical course in Glecaprevir(GLE)/Pibrentasvir(PIB) treated hepatitis C virus infected patients.
To study the RASs, clinical course in comparison between each genotype, investigation into the cause of treatment failed cases are important research question.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The resistance associated substitutions were studied before pre-treatment and non-response or viral breakthrough.

Key secondary outcomes

HCV RNA levels were assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment (EOT) and at 12 and 24 weeks after completion of treatment, and routine biochemical and hematological tests were also performed to evaluate the clinical course.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Glecaprevir(GLE)/Pibrentasvir(PIB) are prescribed according to approved regimen(8 weeks or 12 weeks).

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

Eligible patients were 20 years old and over patients treated with Glecaprevir and Pibrentasvir treatment.

Key exclusion criteria

Patients coinfection with human immunodeficiency virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease are excluded. Patients with uncontrollable other disease and those with alcohol abuse are also excluded.

Target sample size

700

Name of lead principal investigator

1st name	Kanji
Middle name
Last name	Yamaguchi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code

602-8566

Address

465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan

TEL

075-251-5519

Email

fuhideki@koto.kpu-m.ac.jp

Name of contact person

1st name	Hideki
Middle name
Last name	Fujii

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code

802-8566

Address

465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan

TEL

075-251-5519

Homepage URL

http://www.f.kpu-m.ac.jp/k/syokanai/

Email

fuhideki@koto.kpu-m.ac.jp

Institute

Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology

Institute

Department

Personal name

Organization

Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

ethical committee

Address

465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan

Tel

0752515337

Email

rinri@koto.kpu-m.ac.jp

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

2017

Year

11

Month

01

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

Enrolling by invitation

Date of protocol fixation

2017

Year

05

Month

21

Day

Date of IRB

2017

Year

11

Month

24

Day

Anticipated trial start date

2017

Year

12

Month

01

Day

Last follow-up date

2021

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

21

Day

Last modified on

2019

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031325