UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030229 |
|---|---|
| Receipt number | 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 12:10:16 |
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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
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
hmsato@mail1.accsnet.ne.jp
Sponsor or person
Institute
Kasama Chuo Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034528
