UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037785
Receipt number R000043092
Scientific Title Long-term prognosis after achieving SVR in cirrhotic patients with HCV: significance of portal vein and portosystemic shunts
Date of disclosure of the study information 2019/08/24
Last modified on 2021/07/27 00:28:08

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Basic information

Public title

Long-term prognosis after achieving SVR in cirrhotic patients with HCV: significance of portal vein and portosystemic shunts

Acronym

Portosystemic Shunts and DAA Therapies

Scientific Title

Long-term prognosis after achieving SVR in cirrhotic patients with HCV: significance of portal vein and portosystemic shunts

Scientific Title:Acronym

Portosystemic Shunts and DAA Therapies

Region

Japan


Condition

Condition

cirrhotic patients with HCV after achieving SVR by DAA therapies

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the long-term prognosis after achieving SVR by DAAs therapies in cirrhotic patients with HCV, and to clarify the significance of portal vein and portsystemic shunts.

Basic objectives2

Others

Basic objectives -Others

to evaluate long-term prognosis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cumulative occurrence of portal hypertension events up to 3 years after achieving SVR

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

the patients diagnosed has having compensated cirrhosis at baseline of DAA therapies in whom SVR had been obtained at least 3 years prior to the start of this study

Key exclusion criteria

lost-to-follow up

Target sample size

79


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

+81(0)49-276-1198

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

+81(0)49-276-1198

Homepage URL


Email

y_uchida@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University

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, Saitama, Japan

Tel

049-276-1354

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 08 Month 24 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

79

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

unpublished

Outcome measures

unpublished

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 08 Month 20 Day

Date of IRB

2019 Year 08 Month 24 Day

Anticipated trial start date

2019 Year 08 Month 21 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective study


Management information

Registered date

2019 Year 08 Month 24 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=R000043092


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name