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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030229
Receipt No. R000034528
Scientific Title Evaluation of Safety, efficacy, and QOL with Glecaprevir and Pibrentasvir therapy in Dialysis Patients Infected with Hepatitis C Virus
Date of disclosure of the study information 2017/12/04
Last modified on 2017/12/02

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Basic information
Public title Evaluation of Safety, efficacy, and QOL with Glecaprevir and Pibrentasvir therapy in Dialysis Patients Infected with Hepatitis C Virus
Acronym Evaluation of Safety, efficacy, and QOL with Glecaprevir and Pibrentasvir therapy in Dialysis Patients Infected with Hepatitis C Virus
Scientific Title Evaluation of Safety, efficacy, and QOL with Glecaprevir and Pibrentasvir therapy in Dialysis Patients Infected with Hepatitis C Virus
Scientific Title:Acronym Evaluation of Safety, efficacy, and QOL with Glecaprevir and Pibrentasvir therapy in Dialysis Patients Infected with Hepatitis C Virus
Region
Japan

Condition
Condition Chronic hepatitis-C, Chronic Renal failure
Classification by specialty
Hepato-biliary-pancreatic medicine Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of Safety, efficacy, and QOL with Glecaprevir and Pibrentasvir therapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Sustained Virological Response at 12weeks after treatment
Key secondary outcomes Safety and QOL during 6 months after treatment, and the period of treatment

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 Depends on insurance adaptation
Key exclusion criteria Depends on insurance adaptation
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikio Sato
Organization Kasama Chuo Clinic
Division name Internal medicine
Zip code
Address 3633-3 Fukuhara, Kasama-shi, Ibaraki, Japan
TEL 0296-71-6001
Email hmsato@mail1.accsnet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikio Sato
Organization Kasama Chuo Clinic
Division name Internal medicine
Zip code
Address 3633-3 Fukuhara, Kasama-shi, Ibaraki, Japan
TEL 0296-71-6001
Homepage URL
Email hmsato@mail1.accsnet.ne.jp

Sponsor
Institute Kasama Chuo Clinic
Institute
Department

Funding Source
Organization Kasama Chuo Clinic
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
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 12 Month 04 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information HCVRNA, blood biochemistry test findings, symptoms, QOL(SF8), dosage adherence, HDS-R, FAST

Management information
Registered date
2017 Year 12 Month 02 Day
Last modified on
2017 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034528

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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