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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025784
Receipt No. R000029655
Scientific Title Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Date of disclosure of the study information 2017/01/21
Last modified on 2017/01/21

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Basic information
Public title Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Acronym Grazoprevir/Elbasvir therapy for hemodialyzed patients
Scientific Title Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Scientific Title:Acronym Grazoprevir/Elbasvir therapy for hemodialyzed patients
Region
Japan

Condition
Condition hemodialyzed patients with chronic hepatitis C infection
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze Safety and efficacy of Grazoprevir/Elbasvir combination therapy for hemodialyzed patients with chronic hepatitis C 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

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 hemodialyzed patients with genotype 1 chronic hepatitis C, who initiated on Grazoprevir/Elbasvir and asunaprevir between January 2017 and march 2019
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 Patients with albumin <3.0 g/dL
7 Other patients judged to be inappropriate to participate in the study by the primary physician
Target sample size 60

Research contact person
Name of lead principal investigator
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
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
Institute Graduate School of Medicine,
Hokkaido University
Institute
Department

Funding Source
Organization MSD K.K
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 01 Month 21 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 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1 Viral factors: HCV NS5A/NS3 inhibitor resistant mutations
2 Peripheral blood tests WBC, differential WBC, Hb, and Plt
3 Liver function tests AST, ALT, GTP, and ALP
4 Biochemistry LDH, BUN, total bilirubin, direct bilirubin, ALP, GTP, total protein, albumin, creatinine, Na, K, Cl, amylase, and lipase
5 Fibrosis markers hyaluronic acid, type collagen, and AFP
6 Glucose tolerance tests: fasting glucose, insulin, and HbA1c; Lipid metabolism: TC, LDL-C, and TG; Blood coagulation
7 Viral kinetics: serial measurement of viral load
8 IL28B
9 Measurement of liver stiffness by liver biopsy/FibroScan


Management information
Registered date
2017 Year 01 Month 21 Day
Last modified on
2017 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029655

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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