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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000019399 |
Receipt No. | R000022439 |
Scientific Title | Prospective study of Sofosbuvir/Ribavirin for HCV genotype 2 infected Japanese patients |
Date of disclosure of the study information | 2015/11/01 |
Last modified on | 2022/05/03 |
Basic information | ||
Public title | Prospective study of Sofosbuvir/Ribavirin for HCV genotype 2 infected Japanese patients | |
Acronym | IFN free SR study | |
Scientific Title | Prospective study of Sofosbuvir/Ribavirin for HCV genotype 2 infected Japanese patients | |
Scientific Title:Acronym | IFN free SR study | |
Region |
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Condition | |||
Condition | Genotype 2 infected chronic liver diseases | ||
Classification by specialty |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | HCV genotype 2 infected patients with chronic liver disorders.
Patients satisfied the public indication for sofosbuvir and ribavirin |
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Key exclusion criteria | Pregnant women
Decompensated cirrhosis Hepatocellular carcinoma Renal impairment (eGFR<30) Doctors judge as inappropriate |
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Target sample size | 250 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Osaka City University and affiliated hospitals |
Institute | |
Department |
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 | 1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, 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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Patients treated with SOF/RBV from June 1 2015 to December 31 2018
Examination for HCV viral load, AFP, and M2BPGi |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022439 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |