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
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
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
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
