Unique ID issued by UMIN | UMIN000020299 |
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Receipt number | R000023444 |
Scientific Title | A Study on Predictors of Treatment Response to ombitasvir/paritaprevir/r combination therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection |
Date of disclosure of the study information | 2016/01/04 |
Last modified on | 2020/01/07 18:30:48 |
A Study on Predictors of Treatment Response to ombitasvir/paritaprevir/r combination therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection
Predictor of treatment response to Ombitasvir /Paritaprevir/r therapy
A Study on Predictors of Treatment Response to ombitasvir/paritaprevir/r combination therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection
Predictor of treatment response to Ombitasvir /Paritaprevir/r therapy
Japan |
Patients with genotype 1 HCV infection
Hepato-biliary-pancreatic medicine |
Others
NO
To evaluate the efficacy and safety of Ombitasvir /Paritaprevir/r combination therapy in patients with a chronic HCV genotype 1 infection, and investigate predictors of treatment response based on the analyses of viral and host factors
Safety,Efficacy
To investigate the predictors obtained at baseline and affecting the sustained virologic response (SVR) rate/occurrence of adverse drug reactions at follow-up Week 12
Effects of HCV NS3, NS5A mutations as viral factors on virologic response
2) Rate of emergence of drug-resistant variants
3) Presence or absence of a reversal of liver fibrosis
4) Presence or absence of an improvement in AFP levels
5) Effects of glucose/lipid-related factors on treatment response
6) Incidence of AEs
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study.
(1) Subjects
Patients with a chronic HCV infection and compensated cirrhosis who are being treated as outpatients or inpatients at institutions participating in this study
(2) Inclusion criteria
[1] Patients who are 20 years of age or older at the time of informed consent
[2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation
[3] Patients with a chronic HCV genotype 1 infection and compensated cirrhosis who do not meet any of the following exclusion criteria
1) Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia)
2) Patients with severe hepatic impairment
3) Patients with a history of hypersensitivity to HCV protease inhibitors or NS5A inhibitor
4) Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment
5) Patients deemed unsuitable for study entry by their treating physician
6) Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
260
1st name | |
Middle name | |
Last name | Goki Suda |
Hokkaido University
Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
+81-11-716-1161
gsudgast@pop.med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Goki Suda |
Hokkaido University
Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
81-11-716-1161
gsudgast@pop.med.hokudai.ac.jp
Hokkaido University
Hokkaido University
Self funding
NO
北海道大学病院(北海道)
2016 | Year | 01 | Month | 04 | Day |
Unpublished
Completed
2015 | Year | 10 | Month | 26 | Day |
2015 | Year | 10 | Month | 26 | Day |
2016 | Year | 01 | Month | 06 | Day |
2019 | Year | 03 | Month | 31 | Day |
This study is cohort study
Way for subscription
Patients who visit our hospital between January 2016 and march 2019, and meet inclusion criteria are enrolled.
2015 | Year | 12 | Month | 21 | Day |
2020 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023444
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