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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028842
Receipt No. R000033010
Scientific Title Analysis for mechanism of emerging the extremely high tolerance mutations against NS5A inhibitor in genotype 1b HCV after failing to DAAs
Date of disclosure of the study information 2017/09/01
Last modified on 2018/08/28

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Basic information
Public title Analysis for mechanism of emerging the extremely high tolerance mutations against NS5A inhibitor in genotype 1b HCV after failing to DAAs
Acronym Analysis for mechanism of emerging the extremely high tolerance mutations against NS5A inhibitor in genotype 1b HCV after failing to DAAs
Scientific Title Analysis for mechanism of emerging the extremely high tolerance mutations against NS5A inhibitor in genotype 1b HCV after failing to DAAs
Scientific Title:Acronym Analysis for mechanism of emerging the extremely high tolerance mutations against NS5A inhibitor in genotype 1b HCV after failing to DAAs
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the mechanism emerging HCV strain carrying the extremely high tolerance mutation to NS5A inhibitors.
Basic objectives2 Others
Basic objectives -Others To investigate the therapeutic strategy for patients with HCV carrying the extremely high tolerance against NS5A inhibitor; P29del or P32del, after failing to direct-acting antiviral agets (DAAs)therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes genetic analysis for HCV after failing to DAA therapy
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 1.Patients with genotype 1b HCV of genotype 1b with NS5A-P29del or P32del after failing to DAAs therapy.
2.Patients who have consent acquired for secondary use of preserved serum.
Key exclusion criteria Patients who offers to decline participation in this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Mochida
Organization Saitama Medical University
Division name Department of Gastroenterology & Hepatology
Zip code
Address 38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL 049-276-1198
Email smochida@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihito Uchida
Organization Saitama Medical University
Division name Department of Gastroenterology & Hepatology
Zip code
Address 38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL 049-276-1198
Homepage URL
Email y_uchida@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Department of Gastroenterology & Hepatology
Institute
Department

Funding Source
Organization Japan Agency for Medical Reserch and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2017 Year 09 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information HCV genome are extracted from the conserved sera before and after DAA therapy, if avaible, at 1st, 2nd, 3rd and 4th week in treatment.
The obtained HCV genome are analyzed using direct-sequencing and ultra deep-sequencing.

Management information
Registered date
2017 Year 08 Month 26 Day
Last modified on
2018 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033010

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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