UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019400 |
|---|---|
| Receipt number | R000022441 |
| Scientific Title | Prospective study of Sofosbuvir and Ledipasvir for HCV genotype 1 infected Japanese patients |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2023/04/25 09:11:39 |
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Basic information
Public title
Prospective study of Sofosbuvir and Ledipasvir for HCV genotype 1 infected Japanese patients
Acronym
IFN free SL study
Scientific Title
Prospective study of Sofosbuvir and Ledipasvir for HCV genotype 1 infected Japanese patients
Scientific Title:Acronym
IFN free SL study
Region
| Japan |
Condition
Condition
Genotype 1 infected chronic liver diseases
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Efficacy and safety
Basic objectives2
Others
Basic objectives -Others
viral genome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sustained viral response
Key secondary outcomes
Suppression of hepatocarcinogenesis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HCV genotype 1 infected patients with chronic liver disorder
Patients satisfied the public indication for sofosbuvir and ledipasvir
Key exclusion criteria
Pregnant woman
Decompensated cirrhosis
Hepatocellular carcinoma
Renal impairement (eGFR<30ml/min/1.73m2)
Doctors judge as inappropriate
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Tamori |
Organization
Osaka City university Graduate School of Medicine
Division name
Department of Hepatology
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3811
atamori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Tamori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
5458585
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
Osaka City University and affiliated hospitals
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
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
The ethical committee, Osaka City University Hospital
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586, JAPAN
Tel
06-6645-3435
ethics@med.osaka-cu.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
| 2015 | Year | 12 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 28 | Day |
Other
Other related information
Patients treated with SOF/LDV from October 1 2015 to December 31 2019.
Examination of HCV viral load, ALT, Platelet, AFP, and M2BPGi
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022441
