UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031615 |
|---|---|
| Receipt number | R000036089 |
| Scientific Title | Efficacy and safety of Glecaprevir/Pibrentasvir plus Ribavirin in Patients who failed Direct-acting antivirals; DAAs with chronic hepatitis C |
| Date of disclosure of the study information | 2019/03/20 |
| Last modified on | 2018/03/06 20:54:44 |
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Basic information
Public title
Efficacy and safety of Glecaprevir/Pibrentasvir plus Ribavirin in Patients who failed Direct-acting antivirals; DAAs with chronic hepatitis C
Acronym
Retreatment of Patients who failed DAAs with GLE/PIB+RBV
Scientific Title
Efficacy and safety of Glecaprevir/Pibrentasvir plus Ribavirin in Patients who failed Direct-acting antivirals; DAAs with chronic hepatitis C
Scientific Title:Acronym
Retreatment of Patients who failed DAAs with GLE/PIB+RBV
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we aimed to evaluate the efficacy and safety of GLE/PIB plus Ribavirin in Patients who previously failed Direct-acting antivirals; DAAs with chronic hepatitis C
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sustained virologic response 12 weeks after treatment
Key secondary outcomes
Virologic response at 2,4,8,12weeks and sustaind virologic response and safety
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
Orally administration of Glecaprevir(300mg)/Pibrentasvir(120mg) plus weight-based Ribavirin for 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
| 19 | years-old | < |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)chronic HCV genotype1-6 infection (HCV RNA detectable)
2)History of DAA-containing treatment, NS3/4A protease inhibitors, NS5A inhibitors, and NS5B inhibitors
3)Those who received enough explanation for the participation in this study, and obtained written consent
Key exclusion criteria
1) Decompensated cirrhosis(jaundice,refractory ascites,hepatic encephalopathy,esophageal varices,spontaneous bacterial peritonitis)
2) Child-Pugh >6 at screening
3) Patients during treatment regardless of any type of cancer
4) Pregnancy or possible pregnancy and breast feeding
5) Patients with severe heart disease
6) Patients with haemoglobinopathies
7) The patients who meets even one any of the following, neutrophils less than 750 /mm3, platelet counts less than <50000 /mm3, Hb less than 10 g/dl
8) Patients with impaired renal function with chronic kidney failure or creatinine clearance less than 50 ml/min
9) Patient with severe mental diseases such as severe depression, the suicide consideration
10)Patients who cannot keep 6-month contraception after in the dosage and the dosage in the male patients that a partner may become pregnant
11)Patients who was judged to be inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatehiro Kagawa |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
kagawa@tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Hirose |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
s-hirose@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
東海大学医学部付属病院（神奈川県）
東海大学医学部付属大磯病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | 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
| 2018 | Year | 03 | Month | 06 | Day |
Last modified on
| 2018 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036089
