UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018942 |
|---|---|
| Receipt number | R000019469 |
| Scientific Title | Establish a new algorithm for antiviral therapies based on HCV NS5A mutation status in patients with chronic hepatitis C infection. |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/09/08 09:22:29 |
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Basic information
Public title
Establish a new algorithm for antiviral therapies based on HCV NS5A mutation status in patients with chronic hepatitis C infection.
Acronym
New algorithm for antiviral therapies in patients with chronic hepatitis C.
Scientific Title
Establish a new algorithm for antiviral therapies based on HCV NS5A mutation status in patients with chronic hepatitis C infection.
Scientific Title:Acronym
New algorithm for antiviral therapies in patients with chronic hepatitis C.
Region
| Japan |
Condition
Condition
patients with chronic hepatitis C infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Establish a new algorithm for antiviral therapies based on HCV NS5A mutation status in patients with chronic hepatitis C infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SVR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
asunaprevir, daclatasvir
Interventions/Control_2
Simeprevir, peginterferon, ribavirin
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) naive, null responder, patial responder
2) over 20 years old
3) HCV RNA level >100,000 IU/mL for naive patient
4) Dropout patients.
5) ban for pregancy
6) get informed concent
Key exclusion criteria
1) liver failure
2) liver chrosis for SMV group
3) liver disease other than CHC
4) HCC
5) coinfection with HIV and/or HBV
6) other than genotype 1b
7) allegry for drugs i this study
8) contraindication for drugs in this study
9) pregnacy
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Goto |
Organization
Nagoya University
Division name
Gastroenterology and hepatology
Zip code
Address
65 tsuruma showa Nagoya Aichi
TEL
052-741-2111
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Hayashi |
Organization
Nagoya University
Division name
Gastroenterology and hepatology
Zip code
Address
65 tsuruma showa Nagoya Aichi
TEL
052-741-2111
Homepage URL
kazuh@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Janssen
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | 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
| 2015 | Year | 09 | Month | 08 | Day |
Last modified on
| 2016 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019469
