UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015806 |
|---|---|
| Receipt number | R000018391 |
| Scientific Title | Anti-hepatic fibrotic effect by interferon free therapy for patients with chronic liver disease type C |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2021/12/06 09:24:56 |
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Basic information
Public title
Anti-hepatic fibrotic effect by interferon free therapy for patients with chronic liver disease type C
Acronym
IFN free B study
Scientific Title
Anti-hepatic fibrotic effect by interferon free therapy for patients with chronic liver disease type C
Scientific Title:Acronym
IFN free B study
Region
| Japan |
Condition
Condition
Patients with chronic liver disease type C
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of hepatic fibrosis after IFN free therapy with daclatasvir and asunaprevir for HCV genotype 1 patients with chronic liver disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of hepatic fibrosis
Key secondary outcomes
Sustained viral response
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Daclatasvir/Asunaprevir
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
Patients with genotype 1b HCV, chronic liver disease. IFN null responder or IFN ineligible or intolerant
Key exclusion criteria
Liver cancer, Non-compensated hepatic cirrhosis, HIV, Pregnant women
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro TAMORI |
Organization
Osaka City University Hospital
Division name
Department of Hepatology
Zip code
Address
1-5-7 Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
atamori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3811
Homepage URL
atamori@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepatology
Institute
Department
Personal name
Funding Source
Organization
Department of Hepatology
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 31 | 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 | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 17 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2021 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018391
