UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036099
Receipt number R000041124
Scientific Title Safety and efficacy of glecaprevir/pibrentasvir combination therapy for hemodialysis patients with genotype 2 hepatitis C infection
Date of disclosure of the study information 2019/03/06
Last modified on 2022/09/13 18:45:41

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Basic information

Public title

Safety and efficacy of glecaprevir/pibrentasvir combination therapy for hemodialysis patients with genotype 2 hepatitis C infection

Acronym

G/P for HD patients with GT2 HCV

Scientific Title

Safety and efficacy of glecaprevir/pibrentasvir combination therapy for hemodialysis patients with genotype 2 hepatitis C infection

Scientific Title:Acronym

G/P for HD patients with GT2 HCV

Region

Japan


Condition

Condition

HD patients with GT2 HCV infection

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze Safety and efficacy of glecaprevir/pibrentasvir combination therapy for Hemodialysis patients with genotype 2 HCV infection

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sustained virological response
adverse events

Key secondary outcomes

1 efficacy and safety in patients with or without LC
2 association of RAVs and SVR
3 efficacy and safety in patients who previously failed to DAAs
4 RAVs in patients failed to GP therapy
5 improvement of liver function after SVR.
6 improvement of AFP value
7 changes in lipid and glucose metabolism
8 adverse events
9 SVR rate according toage


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

Hemodialysis patients with genotype 2 HCV infecton, who initiated on glecaprevir/pibrentasvir

Key exclusion criteria

1 Patients with a past history of hypersensitivity to HCV protease inhibitors and NS5A inhibitors
2 Patients with serious liver dysfunction (Child-Pugh Class B or C)
3 Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia)
4 Patients who have malignant tumors, including hepatoma, at the start of treatment
5 Patients on treatment with drugs listed in the contraindications for coadministration in the package insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (HIV) protease inhibitors)
6 Other patients judged to be inappropriate to participate in the study by the primary physician

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoya Sakamoto

Organization

Graduate School of Medicine,
Hokkaido University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

North 15, West 7, Kita-ku, Sapporo, Hokkaido

TEL

011-716-2111

Email

gsudgast@pop.med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Goki Suda

Organization

Graduate School of Medicine,Hokkaido University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

North 15, West 7, Kita-ku, Sapporo, Hokkaido

TEL

011-716-2111

Homepage URL


Email

gsudgast@pop.med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

AbbVie GK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

2019 Year 03 Month 06 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

2018 Year 01 Month 31 Day

Date of IRB

2018 Year 01 Month 31 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

clinical data
blood test


Management information

Registered date

2019 Year 03 Month 06 Day

Last modified on

2022 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name