UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016995 |
|---|---|
| Receipt number | R000019715 |
| Scientific Title | Evaluation of antiviral effects of the combination therapy of daclatasvir and asunaprevir |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2015/03/31 18:14:29 |
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Basic information
Public title
Evaluation of antiviral effects of the combination therapy of daclatasvir and asunaprevir
Acronym
GLSG DCV/ASV
Scientific Title
Evaluation of antiviral effects of the combination therapy of daclatasvir and asunaprevir
Scientific Title:Acronym
GLSG DCV/ASV
Region
| Japan |
Condition
Condition
chronic hepatitis C with genotype 1
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To extend the subjects such as patients with dialysis, patients after curative treatment of HCC (including HCC developing at a younger age), patients with collagen diseases, patients with autoimmune hepatitis and evaluate the efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
antiviral effect (SVR24)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic hepatitis C with genotype 1
Key exclusion criteria
1. Patients having the history of allergy to Daclatasvir and Asunaprevir
2. Women with pregnancy, having a possibility of pregnancy and during lactation
3. Patients taking a medicine described as a contraindication in a package insert. However, these patients can participate the study one month after discontinuation of the drug.
4. Patients whom the primary doctor thinks inapproprioate for participating the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8127
satoken@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511
TEL
027-220-8127
Homepage URL
satoken@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gunma University Graduate School of Medicine
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
| 2019 | Year | 10 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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
This study is underway.
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019715
