UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037575 |
|---|---|
| Receipt number | R000042836 |
| Scientific Title | Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2024/08/04 11:22:24 |
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Basic information
Public title
Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
Acronym
Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
Scientific Title
Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
Scientific Title:Acronym
Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
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 investigate treatment effects of interferon-free treatment on prognosis, and factors contributing to treatment effects
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sustained virological response rates at 24weeks after the end of treatment
Key secondary outcomes
factors contributing to sustained virological response
appearance of RAS(resistant associated substitutions)
occurrence of hepatocellular carcinoma
factors associated with occurrence of hepatocellular carcinoma
changes in liver fibrosis and liver function
life prognosis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are 20 years of age or older
2. Patients with chronic hepatitis C
3. Patients who are treated with interferon-free treatment
Key exclusion criteria
1. Patients treated with contraindicated drug together with direct acting antivirals
2. Patients who were judged inadequate to participate by researchers.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Graduate school of medicine, Osaka university
Division name
department of gastroenterology and hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Tahata |
Organization
Graduate school of medicine, Osaka university
Division name
department of gastroenterology and hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3621
Homepage URL
yuki.tahata@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
| 2019 | Year | 08 | 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
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042836
