UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026917 |
|---|---|
| Receipt number | R000030877 |
| Scientific Title | Daclatasvir/Asunaprevir/Beclabuvir regulates innate immunity by inhibition of nonstructural 5B and suppresses liver fibrosis development |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2018/10/30 18:28:50 |
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Basic information
Public title
Daclatasvir/Asunaprevir/Beclabuvir regulates innate immunity by inhibition of nonstructural 5B and suppresses liver fibrosis development
Acronym
Daclatasvir/Asunaprevir/Beclabuvir regulates innate immunity by inhibition of nonstructural 5B and suppresses liver fibrosis development
Scientific Title
Daclatasvir/Asunaprevir/Beclabuvir regulates innate immunity by inhibition of nonstructural 5B and suppresses liver fibrosis development
Scientific Title:Acronym
Daclatasvir/Asunaprevir/Beclabuvir regulates innate immunity by inhibition of nonstructural 5B and suppresses liver fibrosis development
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clinically evaluate the effect of Daclatasvir(DCV)/Asunaprevir(ASV)/Beclabuvir(BCV) on liver fibrosis develpment via regulation of innate immunity for the patients with chronic hepatitis C. Additionally, the alteration of gut microbiome along with clearance of HCV by DCV/ASV/BCV will be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pathological change in liver fibrosis in the patients with between pretreatment and 36 weeks after therapeutic intervention
Key secondary outcomes
Change in serum fibrogenic markers and gu microbiome in the patients with between pretreatment and 36 weeks after therapeutic intervention
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients with HCV genotype1 which are categorized as F2, F3 or F4 by New Inuyama Classification
Key exclusion criteria
1. With other concomitant chronic liver diseases including Heptitis B, Autoimmune hepatitis, Primary biliary cholangitis, Primary sclerosing cholangitis, Alcoholic steatohepatitis, Nonalcoholic steatohepatitis, Hemochromatosis or Wilson's disease.
2. With decompensated cirrhosis
3. With cancers, severe cardiopulmonary or renal diseases or inflammatory bowel diseases.
4. With previous history of gastrectomy, enterectomy or liver transplantation.
5. With treatment of immunosuppressants, antibiotics, probiotics, proton pump inhibitors or H2 blockers.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Yoshiji |
Organization
Nara Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051(ext.3415)
yoshijij@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Kaji |
Organization
Nara Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051(ext.3415)
Homepage URL
kajik@naramed-u.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb
Organization
Division
Category of Funding Organization
Other
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
奈良県立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | 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
We perform a prospective observational study to evaluate the antifibrotic effect of DCV/ASV/BCV. The subjects are HCV patients which will undergo the treatment with this drug.
Management information
Registered date
| 2017 | Year | 04 | Month | 09 | Day |
Last modified on
| 2018 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030877
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
