UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025085 |
|---|---|
| Receipt number | R000028823 |
| Scientific Title | Efficacy and safety of ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir /grazoprevir, glecaprevir/pibrentasvir after curative treatment of HCV-Related HCC - Prospective multicenter-cooperative cohort study |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2019/06/03 09:12:25 |
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Basic information
Public title
Efficacy and safety of ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir /grazoprevir, glecaprevir/pibrentasvir after curative treatment of HCV-Related HCC - Prospective multicenter-cooperative cohort study
Acronym
Ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir/grazoprevir,
glecaprevir/pibrentasvir therapy in HCV-Related HCC patients - Prospective multicenter-cooperative cohort study
Scientific Title
Efficacy and safety of ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir /grazoprevir, glecaprevir/pibrentasvir after curative treatment of HCV-Related HCC - Prospective multicenter-cooperative cohort study
Scientific Title:Acronym
Ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir/grazoprevir,
glecaprevir/pibrentasvir therapy in HCV-Related HCC patients - Prospective multicenter-cooperative cohort study
Region
| Japan |
Condition
Condition
HCV-related hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate efficacy and safety of Ombitasvir/paritaprevir/ritonavir therapy after curative treatment of HCV-Related HCC. We will also evaluate recurrence of HCC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication ratio of HCV 24 weeks after treatment
Key secondary outcomes
Adverse events and side effects
Recurrence of HCC
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
Ombitasvir/paritaprevir/ritonavir therapy for HCV
Patients will receive 2 tablets of Viekirax after meal once daily for 12 weeks. Each film coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients at the age between 20 and 90 years old
2)Patients providing written informed consent
3)Patients who will have IFN-free therapy for HCV after curative treatment for HCC
Key exclusion criteria
1)Patients who have a history of hypersensitivity to Omvitasvir/paritaprevir/ritonavir
2)Patients who are excluded from HCV eradication therapy because of decompensated cirrhosis and others
3)Patients who cannot receive IFN-free therapy because of concomitant medication etc.
4)Women who are or may be pregnant
5)Patients considered to be ineligible for participation in the study by the investigator or subinvestigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shuichiro |
| Middle name | |
| Last name | Shiina |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology (Department of Diagnostic Imaging and Minimally Invasive Therapy)
Zip code
1138421
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3811
sshiina@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuichiro |
| Middle name | |
| Last name | Shiina |
Organization
1956
Division name
Department of Gastroenterology (Department of Diagnostic Imaging and Minimally Invasive Therapy)
Zip code
1138421
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3811
Homepage URL
ivo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University 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
Juntendo University Nerima Hospital
Japanese Red Cross Medical Center
Mitsui Memorial Hospital
Kyoundo Hospital
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
ivo@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）
順天堂大学医学部附属練馬病院（東京都）
日本赤十字社医療センター（東京都）
三井記念病院（東京都）
佐々木研究所附属杏雲堂病院（東京都）
東京都健康長寿医療センター（東京都）
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028823
