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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000031664 |
Receipt No. | R000036166 |
Scientific Title | Evaluation of the efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients: a prospective study in real life settings. |
Date of disclosure of the study information | 2018/03/12 |
Last modified on | 2018/12/16 |
Basic information | ||
Public title | Evaluation of the efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients: a prospective study in real life settings. | |
Acronym | The efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients. | |
Scientific Title | Evaluation of the efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients: a prospective study in real life settings. | |
Scientific Title:Acronym | The efficacy of glecaprevir and pibrentasvir for Japanese hepatitis C patients. | |
Region |
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Condition | ||
Condition | cirrhotic and non cirrhotic patients with chronic hepatitis C virus | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | Identifying the predictive factors of virological response in glecaprevir and pibrentasvir treatment. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | sustained virological response (SVR) at 12 week and 24 week after the end of treatment |
Key secondary outcomes | incidence rate of adverse events
sustained virological response (SVR) at 4 week after the end of treatment |
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 | chronic hepatitis C and compensated cirrhotic patients with HCV RNA | |||
Key exclusion criteria | decompensated cirrhosis | |||
Target sample size | 350 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Toranomon Hospital | ||||||
Division name | hepatology | ||||||
Zip code | |||||||
Address | 2-2-2, Toranomon, Minato-ku, Tokyo | ||||||
TEL | 03-3588-1111 | ||||||
hitomis@mx1.harmonix.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | Toranomon Hospital | ||||||
Division name | hepatology | ||||||
Zip code | |||||||
Address | 2-2-2, Toranomon, Minato-ku, Tokyo | ||||||
TEL | 03-3588-1111 | ||||||
Homepage URL | |||||||
hitomis@mx1.harmonix.ne.jp |
Sponsor | |
Institute | Toranomon Hospital |
Institute | |
Department |
Funding Source | |
Organization | Japan Agency for Medical Research and Development |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization | Japan |
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 | 虎の門病院(東京都) |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | combination tablet of glecaprevir /pibrentasvir(100mg/40mg) three tablets once daily for 8 weeks or 12 weeks
Evaluating the association with baseline characteristics (viral factors and host factors) and virological response. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036166 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |