Unique ID issued by UMIN | UMIN000018947 |
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Receipt number | R000021917 |
Scientific Title | A Study on Predictors of Treatment Response to Sofosbuvir and Ribavirin Therapy in Patients with genotype 2 Chronic Hepatitis C Virus Infection |
Date of disclosure of the study information | 2015/09/08 |
Last modified on | 2022/10/06 10:06:59 |
A Study on Predictors of Treatment Response to Sofosbuvir and Ribavirin Therapy in Patients with genotype 2 Chronic Hepatitis C Virus Infection
Predictor of treatment response to SOF /RBV therapy
A Study on Predictors of Treatment Response to Sofosbuvir and Ribavirin Therapy in Patients with genotype 2 Chronic Hepatitis C Virus Infection
Predictor of treatment response to SOF /RBV therapy
Japan |
Patients with genotype 2 HCV infection
Hepato-biliary-pancreatic medicine |
Others
NO
To evaluate the efficacy and safety of sofosbuvir plus ribavirin therapy in patients with a chronic HCV genotype 2 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 NS5B 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 2 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 NS5B inhibitors or Ribavirin
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 with severe renal dysfunction
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 Department of Gastroenterology and Hepatology, Graduate School of Medicine,
none
Self funding
NO
2015 | Year | 09 | Month | 08 | Day |
Unpublished
Completed
2015 | Year | 05 | Month | 12 | Day |
2015 | Year | 06 | Month | 16 | Day |
2015 | Year | 09 | Month | 08 | Day |
2019 | Year | 04 | Month | 03 | Day |
This study is cohort study
Way for subscription
Patients who visit our hospital between June 2015 and march 2018, and meet inclusion criteria are enrolled.
We will check below
1 Viral factors: HCV NS5A/NS3 inhibitor resistant mutations
2 Peripheral blood tests: WBC, differential WBC, Hb, and Plt
3 Liver function tests AST, ALT, GTP, and ALP
4 Biochemistry LDH, BUN, total bilirubin, direct bilirubin, ALP, GTP, total protein, albumin, creatinine, Na, K, Cl, amylase, and lipase
5 Fibrosis markers: hyaluronic acid, type IV collagen etc, and AFP
6 Glucose tolerance tests: fasting glucose, insulin, and HbA1c Lipid metabolism: TC, LDL-C, and TG; Blood coagulation
7 Viral kinetics: serial measurement of viral titer
8 Measurement of liver stiffness by liver biopsy/FibroScan
2015 | Year | 09 | Month | 08 | Day |
2022 | Year | 10 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021917
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