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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034794
Receipt No. R000039679
Official scientific title of the study 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 2018/11/07

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Basic information
Official scientific title of the study Therapeutic effect and related factors of glecaprevir/pibrentasvir combination therapy for hepatitis C infected patients
Title of the study (Brief title) 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 Noriyuki Akutsu
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
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 Noriyuki Akutsu
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
Address Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email akutsu@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 12 Month 15 Day
Anticipated trial start date
2018 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Prospective observational study

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.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


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