UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014971
Receipt number R000017401
Scientific Title Comparison of DAAs(Direct Acting Antivirals) and interferon-based triple therapy for hepatitis C after treatment of hepatocelluler carcinoma.
Date of disclosure of the study information 2014/09/01
Last modified on 2018/08/30 15:15:09

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Basic information

Public title

Comparison of DAAs(Direct Acting Antivirals) and interferon-based triple therapy for hepatitis C after treatment of hepatocelluler carcinoma.

Acronym

Antiviral therapy for HCV after treatment of hepatocelluler carcinoma.

Scientific Title

Comparison of DAAs(Direct Acting Antivirals) and interferon-based triple therapy for hepatitis C after treatment of hepatocelluler carcinoma.

Scientific Title:Acronym

Antiviral therapy for HCV after treatment of hepatocelluler carcinoma.

Region

Japan


Condition

Condition

Hepatitis C after treatment for hepatocelluler carcinoma.

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To clarify the antiviral therapy for inhibition of recurrence after treatment for hepatocelluler carcinoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

incidence of recurrence
survival rate

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) HCV genotype 1b
2) Neutrophil >=1,500 /mm3
PLT >= 75,000 /mm3
3) >=3 months post HCC treatment
4) CH or LC(Child-Pugh A)
5) within HCC stage 3
6) including post PSE/splenectomy cases

Key exclusion criteria

Patients judged by doctor that participation in the study is improper

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouji Joko

Organization

Matsuyama Red Cross Hospital

Division name

Center for liver-Biliary-Pancreatic Diseases

Zip code


Address

1 Bunkyo-cho, Matsuyama-shi, EHIME

TEL

089-924-1111

Email

Koujijoko@matsuyama.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshie Mashiba

Organization

Matsuyama Red Cross Hospital

Division name

Center for liver-Biliary-Pancreatic Diseases

Zip code


Address

1 Bunkyo-cho, Matsuyama-shi, EHIME

TEL

089-924-1111

Homepage URL


Email

matoshi@matsuyama.jrc.or.jp


Sponsor or person

Institute

Musashino Red Cross Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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



Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Main results already published

Date of protocol fixation

2014 Year 08 Month 25 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Comparison of DAAs(daclatasvir and asunaprevir) and interferon-based triple therapy for hepatitis C after treatment for hepatocelluler carcinoma in Red Cross Hospital in Japan.


Management information

Registered date

2014 Year 08 Month 27 Day

Last modified on

2018 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017401


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name