UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027428 |
|---|---|
| Receipt number | 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 | 2019/11/24 14:42:58 |
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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
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/
fuhideki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
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
ethical committee
Address
465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
Tel
0752515337
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 | 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
