UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028842
Receipt number 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 2021/07/27 00:28:44

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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 Satoshi
Middle name
Last name Mochida

Organization

Saitama Medical University

Division name

Department of Gastroenterology & Hepatology

Zip code

350-0495

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 Yoshihito
Middle name
Last name Uchida

Organization

Saitama Medical University

Division name

Department of Gastroenterology & Hepatology

Zip code

350-0495

Address

38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan

TEL

049-276-1198

Homepage URL


Email

y_uchida@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University Department of Gastroenterology & Hepatology

Institute

Department

Personal name



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

the Institutional Review Board of Saitama Medical University Hospital

Address

38 Morohongo, Moroyama-cho, Iruma-gun, Saitama, Japan

Tel

049-276-1125

Email

hirb@saitama-med.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 09 Month 01 Day


Related information

URL releasing protocol

unpublished

Publication of results

Unpublished


Result

URL related to results and publications

unpublished

Number of participants that the trial has enrolled

11

Results

unpublished

Results date posted

2021 Year 07 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

unpublished

Participant flow

unpublished

Adverse events

none

Outcome measures

unpublished

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 09 Month 01 Day

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

2021 Year 07 Month 27 Day



Link to view the page

Value
https://center6.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