UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035625
Receipt number R000040581
Scientific Title Efficacy and safety of sofosbuvir/belpatasvir combination tablets for patients infected with pan-genotypic hepatitis C virus
Date of disclosure of the study information 2019/01/23
Last modified on 2022/07/26 09:16:17

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Basic information

Public title

Efficacy and safety of sofosbuvir/belpatasvir combination tablets for patients infected with pan-genotypic hepatitis C virus

Acronym

Sofosbuvir/velpatasvir therapy for patients with HCV

Scientific Title

Efficacy and safety of sofosbuvir/belpatasvir combination tablets for patients infected with pan-genotypic hepatitis C virus

Scientific Title:Acronym

Sofosbuvir/velpatasvir therapy for patients with HCV

Region

Japan


Condition

Condition

Chronic liver disease infected with HCV

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of sofosbuvir/velpatasvir combination tablets for patients infected with pan-genotypic hepatitis C virus, and analyze the viral factors associated with non-SVR.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rates of Sustained virological response at 12 and 24 weeks after the end of treatment

Key secondary outcomes



Base

Study type

Observational


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients infected with HCV

Key exclusion criteria

1) Patients who do not have consent to clinical research
2) Patietns accompanying HCC
2) Patients with pregnancy

Target sample size

60


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

3500495

Address

38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan

TEL

049-276-1198

Email

smochida@saitama-med.ac.jp


Public contact

Name of contact person

1st name Uchida
Middle name
Last name Yoshihito

Organization

Saitama Medical University

Division name

Department of Gastroenterology & Hepatology

Zip code

3500495

Address

38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan

TEL

049-276-1198

Homepage URL


Email

y_uchida@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

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, 350-0495 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

2019 Year 01 Month 23 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

35

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

2019 Year 01 Month 21 Day

Date of IRB

2019 Year 02 Month 04 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

obsevatinal cohort study.


Management information

Registered date

2019 Year 01 Month 22 Day

Last modified on

2022 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040581


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name