UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034794
Receipt number R000039679
Scientific Title Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients
Date of disclosure of the study information 2018/11/07
Last modified on 2020/11/08 10:57:50

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Basic information

Public title

Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients

Acronym

Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients

Scientific Title

Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients

Scientific Title:Acronym

Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients

Region

Japan


Condition

Condition

patients with HCV infection

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for HCV patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sustained virological response

Key secondary outcomes

1.Safety
2.Factors in patients who failed to antiviral therapy
3.Changes in lipid metabolism


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

1)Patients with chronic hepatitis or compensated cirrhosis
2)Child-Pugh Score 5 or 6
3)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
4)Adequate functional reserve of major organs
5)Over 20 years old
6)Capable of complying with requirements with respect to visit days, medication, and laboratory tests
7)The patient provides written informed consent before the start of the clinical study

Key exclusion criteria

1)History of hypersensitivity to any component of the study drug
2)Receiving contraindicated drugs for Elbasvir/Grazoprevir combined therapy
3)Esophageal varices with the potential to bleed
4)Any of the following diseases within 12 months before enrollment in the clinical study: myocardial infarction, unstable angina, cardiac failure, and cerebrovascular disorder
5)Patients with active hepatocellular carcinoma
6)Patients with brain tumor
7)Patients with active double cancer
8)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease
9)Pregnant or nursing
10)Otherwise found by the investigator or subinvestigator to be ineligible as a subject

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Noriyuki
Middle name
Last name Akutsu

Organization

Sapporo Medical University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

0608543

Address

Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Email

akutsu@sapmed.ac.jp


Public contact

Name of contact person

1st name Noriyuki
Middle name
Last name Akutsu

Organization

Sapporo Medical University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

0608543

Address

Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Homepage URL


Email

akutsu@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of Sapporo Medical University School of Medicine

Address

Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan

Tel

011-611-2111

Email

ji-rskk@sapmed.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

札幌医科大学附属病院医学部 消化器内科、手稲渓仁会病院 消化器病センター、
市立釧路総合病院 消化器内科、函館五稜郭病院 消化器内科、
市立小樽病院 消化器内科、市立室蘭総合病院 消化器内科、
帯広協会病院 消化器内科、札幌禎心会病院 消化器内科、
JR札幌病院 内科、天使病院 消化器内科、札幌里塚病院 内科、
済生会小樽病院 消化器内科、札幌外科記念病院内科、
同交会病院 内科、札幌しらかば台病院 消化器内科


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 07 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

Completed

Date of protocol fixation

2017 Year 12 Month 15 Day

Date of IRB

2018 Year 01 Month 11 Day

Anticipated trial start date

2018 Year 01 Month 11 Day

Last follow-up date

2019 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study


Management information

Registered date

2018 Year 11 Month 07 Day

Last modified on

2020 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name