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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031615
Receipt No. 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

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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
Email 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
Email s-hirose@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036089

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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