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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027428
Receipt No. R000031325
Scientific Title Retrospective cohort study of resistance associated substitutions and clinical course in Glecaprevir(GLE)/Pibrentasvir(PIB) treatment to hepatitis C virus
Date of disclosure of the study information 2017/11/01
Last modified on 2019/05/26

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Basic information
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
Condition Hepatitis C virus infected patients
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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 11 Month 01 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 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
Other related information

Management information
Registered date
2017 Year 05 Month 21 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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