UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025085
Receipt number R000028823
Scientific Title Efficacy and safety of ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir /grazoprevir, glecaprevir/pibrentasvir after curative treatment of HCV-Related HCC - Prospective multicenter-cooperative cohort study
Date of disclosure of the study information 2016/12/01
Last modified on 2019/06/03 09:12:25

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Basic information

Public title

Efficacy and safety of ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir /grazoprevir, glecaprevir/pibrentasvir after curative treatment of HCV-Related HCC - Prospective multicenter-cooperative cohort study

Acronym

Ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir/grazoprevir,

glecaprevir/pibrentasvir therapy in HCV-Related HCC patients - Prospective multicenter-cooperative cohort study

Scientific Title

Efficacy and safety of ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir /grazoprevir, glecaprevir/pibrentasvir after curative treatment of HCV-Related HCC - Prospective multicenter-cooperative cohort study

Scientific Title:Acronym

Ombitasvir/paritaprevir/ritonavir, ledipasvir/sofosbuvir, elbasvir/grazoprevir,

glecaprevir/pibrentasvir therapy in HCV-Related HCC patients - Prospective multicenter-cooperative cohort study

Region

Japan


Condition

Condition

HCV-related hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We will evaluate efficacy and safety of Ombitasvir/paritaprevir/ritonavir therapy after curative treatment of HCV-Related HCC. We will also evaluate recurrence of HCC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Eradication ratio of HCV 24 weeks after treatment

Key secondary outcomes

Adverse events and side effects
Recurrence of HCC


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ombitasvir/paritaprevir/ritonavir therapy for HCV

Patients will receive 2 tablets of Viekirax after meal once daily for 12 weeks. Each film coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Patients at the age between 20 and 90 years old
2)Patients providing written informed consent
3)Patients who will have IFN-free therapy for HCV after curative treatment for HCC

Key exclusion criteria

1)Patients who have a history of hypersensitivity to Omvitasvir/paritaprevir/ritonavir
2)Patients who are excluded from HCV eradication therapy because of decompensated cirrhosis and others
3)Patients who cannot receive IFN-free therapy because of concomitant medication etc.
4)Women who are or may be pregnant
5)Patients considered to be ineligible for participation in the study by the investigator or subinvestigators

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Shuichiro
Middle name
Last name Shiina

Organization

Juntendo University Hospital

Division name

Department of Gastroenterology (Department of Diagnostic Imaging and Minimally Invasive Therapy)

Zip code

1138421

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3811

Email

sshiina@juntendo.ac.jp


Public contact

Name of contact person

1st name Shuichiro
Middle name
Last name Shiina

Organization

1956

Division name

Department of Gastroenterology (Department of Diagnostic Imaging and Minimally Invasive Therapy)

Zip code

1138421

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3811

Homepage URL


Email

ivo@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Juntendo University Nerima Hospital
Japanese Red Cross Medical Center
Mitsui Memorial Hospital
Kyoundo Hospital
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Keio University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University Hospital

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

Tel

03-3813-3111

Email

ivo@juntendo.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

順天堂大学医学部附属順天堂医院(東京都)
順天堂大学医学部附属練馬病院(東京都)
日本赤十字社医療センター(東京都)
三井記念病院(東京都)
佐々木研究所附属杏雲堂病院(東京都)
東京都健康長寿医療センター(東京都)
慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 12 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

Open public recruiting

Date of protocol fixation

2016 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2016 Year 12 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



Management information

Registered date

2016 Year 11 Month 30 Day

Last modified on

2019 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028823


Research Plan
Registered date File name
2018/06/05 研究計画書(2018ver.).docx

Research case data specifications
Registered date File name
2018/06/11 順天堂大学(1症例分).xls

Research case data
Registered date File name