UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016355 |
|---|---|
| Receipt number | R000018993 |
| Scientific Title | Safety and efficacy of Daclatasvir and Asunaprevir combination therapy for hemodialyzed patients with chronic hepatitis C |
| Date of disclosure of the study information | 2015/01/28 |
| Last modified on | 2022/10/06 10:03:42 |
* 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
Safety and efficacy of Daclatasvir and Asunaprevir combination therapy for hemodialyzed patients with chronic hepatitis C
Acronym
Daclatasvir and Asunaprevir therapy for hemodialyzed ptatients
Scientific Title
Safety and efficacy of Daclatasvir and Asunaprevir combination therapy for hemodialyzed patients with chronic hepatitis C
Scientific Title:Acronym
Daclatasvir and Asunaprevir therapy for hemodialyzed ptatients
Region
| Japan |
Condition
Condition
hemodialyzed patients with chronic hepatitis C
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze Safety and efficacy of Daclatasvir and Asunaprevir combination therapy for hemodialyzed patients with chronic hepatitis C
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hemodialyzed patients with chronic hepatitis C
Key exclusion criteria
1 patients with heart failure
2 patients with decompensated cirrhosis
3 patients with allergic to NS5A inhibitor or HCV PI inhibitor
4 patients with HCC or other malignant disease
Target sample size
100
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
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
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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 | 28 | 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 | 09 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Safety and efficacy of Daclatasvir and Asunaprevir combination therapy
Management information
Registered date
| 2015 | Year | 01 | Month | 27 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018993
