UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034735 |
|---|---|
| Receipt number | R000039600 |
| Scientific Title | Long-term effect of interferon-free treatment in subjects with hepatitis C virus (HCV)-related decompensated cirhosis |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2024/11/05 17:00:09 |
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Basic information
Public title
Long-term effect of interferon-free treatment in subjects with hepatitis C virus (HCV)-related decompensated cirhosis
Acronym
DAA for decompensatd cirrhosis
Scientific Title
Long-term effect of interferon-free treatment in subjects with hepatitis C virus (HCV)-related decompensated cirhosis
Scientific Title:Acronym
DAA for decompensatd cirrhosis
Region
| Japan |
Condition
Condition
decompensated cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the long-term efficacy for velpatasvir and sofosbuvir with or without ribavirin therapy for Hepatitis C Virus infection in patients with decompensated cirrhosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Child-Pugh score, MELD score
HCC occurence rate
Key secondary outcomes
Survival rate
Incidence rate of gastroesophageal varix rupture
Factors associated with improvement in liver function
Factors associated with HCC occurrence
Factors associated with survival
Factors associated with gastroesophageal varix rupture
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
Patients in clinical trial of Velpatasvir/Sofosbuvir with or without ribavirin in Japan
Key exclusion criteria
none
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
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
Osaka University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
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
Osaka 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
Osaka University Clinical Research Review Committee
Address
Yamadaoka 2-2, Suita city, Osaka
Tel
06-6210-8296
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
| 2018 | Year | 11 | 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
99
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039600
