UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016181 |
|---|---|
| Receipt number | R000018783 |
| Scientific Title | Efficacy and safety of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis |
| Date of disclosure of the study information | 2015/01/14 |
| Last modified on | 2016/08/31 23:53:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Acronym
Efficacy of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Scientific Title
Efficacy and safety of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Scientific Title:Acronym
Efficacy of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Region
| Japan |
Condition
Condition
Chronic hepatitis C with hemodialysis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assessment of efficacy and safety of daclatasvir and asunaprevir in chronic hepatits C patients with hemodialysis .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Sustained virologic response rate at 24 weeks post-treatment
Key secondary outcomes
Safety
The factor associated with sustained virologic response
Emergence of drug-resistant virus
Cumulative incidence of hepatocellular carcinoma
Base
Study type
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) Chronic hepatitis or cirrhosis patients with HCV genotype 1
(2) Patients with hemodialysis
(3) Patients with 20 years of age and older
Key exclusion criteria
(1) Decompensated cirrhosis, Liver failure
(2)patients with hepatic cell carcinoma
(3) Co-infection with hepatitis B virus
Co-infection with anti- humanimmunodeficiency virus
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | uojima haruki |
Organization
shonan kamakura general hospital
Division name
department of gastroenterology
Zip code
Address
1370-1 okamoto,kamakura, kanagawa, japan
TEL
0467-46-1717
kiruha555@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | uojima haruki |
Organization
shonan kamakura general hospital
Division name
department of gastroenterology
Zip code
Address
1370-1 o,kamakura, kanagawa, japan
TEL
0467-46-1717
Homepage URL
kiruha555@yahoo.co.jp
Sponsor or person
Institute
shonan kamakura general hospital
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
| 2015 | Year | 01 | Month | 14 | 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 | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2015 | Year | 01 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018783
