UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015882 |
|---|---|
| Receipt number | R000018485 |
| Scientific Title | A multicenter phase II study assessed safety and efficacy of asunaprevir and daclatasvir in patients with chronic hepatitis C virus genotype 1 infection and end-stage renal disease requiring hemodialysis |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2017/06/11 11:20:43 |
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Basic information
Public title
A multicenter phase II study assessed safety and efficacy of asunaprevir and daclatasvir in patients with chronic hepatitis C virus genotype 1 infection and end-stage renal disease requiring hemodialysis
Acronym
A phase II study of asunaprevir and daclatasvir in patients requiring hemodialysis with chronic hepatitis C
Scientific Title
A multicenter phase II study assessed safety and efficacy of asunaprevir and daclatasvir in patients with chronic hepatitis C virus genotype 1 infection and end-stage renal disease requiring hemodialysis
Scientific Title:Acronym
A phase II study of asunaprevir and daclatasvir in patients requiring hemodialysis with chronic hepatitis C
Region
| Japan |
Condition
Condition
Chronic hepatitis C with end-stage renal disease requiring hemodialysis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of of asunaprevir and daclatasvir in patients with chronic hepatitis and end-stage renal disease requiring hemodialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virological response at 12 weeks post-treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Asunaprevir 200mg twice daily and daclatasvir 60mg once daily for 24 weeks.
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 undergoing chronic hemodialysis.
2) Patients with chronic hepatitis or compensated cirrhosis infected with hepatitis C virus genotype 1.
Key exclusion criteria
1) Patients who have malignant neoplasm, including hepatocellular carcinoma.
2) Patients with decompensated cirrhosis.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwata Ozaki |
Organization
Saga University Hospital
Division name
Hepatology Division
Zip code
Address
5-1-1 Nabeshima, Saga-Shi, Saga
TEL
0952-34-2362
ozaki@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiga Otsuka |
Organization
Saga University Hospital
Division name
Hepatology Division
Zip code
Address
5-1-1 Nabeshima, Saga-Shi, Saga
TEL
0952-34-2362
Homepage URL
otsuka-t@umin.ac.jp
Sponsor or person
Institute
Saga Study Group of Liver Diseases
Institute
Department
Personal name
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)
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
| 2014 | Year | 12 | Month | 10 | 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
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 09 | Day |
Last modified on
| 2017 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018485
