UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044234 |
|---|---|
| Receipt number | R000050518 |
| Scientific Title | Effect and adverse effect of direct acting antivirals |
| Date of disclosure of the study information | 2021/05/18 |
| Last modified on | 2021/05/17 21:04:49 |
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Basic information
Public title
Effect and adverse effect of direct acting antivirals for the patients with HCV
Acronym
Effect and adverse effect of direct acting antivirals for the patients with HCV
Scientific Title
Effect and adverse effect of direct acting antivirals
Scientific Title:Acronym
Effect and adverse effect of direct acting antivirals
Region
| Japan |
Condition
Condition
Chronic hepatitis, type C, Liver cirrhosis, type C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the efficacy and the frequencies of adverse effect in the patients with HCV receiving direct acting antivirals therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sustained virological response
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
Administration of DAAs
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. more than 20 years old
2. patient with genotype 1b HCV
3. over 50,000/ micro litter of platelet
4. the patient received curative HCC treatment (if experienced HCC)
5. the patient received explanation and consent
6. HCV RNA positive (if treatment naive patient)
Key exclusion criteria
1. the female patient in pregnancy or breast-feeding
2. the patient experienced allergic reaction for daclatasvir and or asunaprevir
3. the liver cirrhosis patient with over Child-pugh score 7
4. the patient whose blood examination data was below the standard value
5. the patient the investigator judged unsuitable for study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakao |
Organization
Nagasaki university hospital
Division name
Department of gastroenterology and hepatology
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki city
TEL
0958197481
kazuhiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Naota |
| Middle name | |
| Last name | Taura |
Organization
Nagasaki university hospital
Division name
Department of gastroenterology and hepatology
Zip code
8528117
Address
Sakamoto 1-7-1, Nagasaki city
TEL
0958197481
Homepage URL
ntaura-g@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of gastroenterology and hepatology, Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of gastroenterology and hepatology, Nagasaki 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
Clinincal research center, Nagasaki university hospital
Address
1-7-1 Sakamoto
Tel
0958197726
samamoto@nagasaki-u.ac.jp
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
| 2021 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
The study was aborted.
Publication of results
Unpublished
Result
URL related to results and publications
The study was aborted.
Number of participants that the trial has enrolled
0
Results
Although a research design was planed, the study was aborted.
Results date posted
| 2021 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No participant
Participant flow
No participant
Adverse events
None (No participant)
Outcome measures
The study was aborted.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2021 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050518
