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Efficacy and safe of Ledipasvir/Sofosbuvir with Ribavirin in Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C-multicenter,pilot study

Phase 2
Conditions
Chronic hepatitis C
Registration Number
JPRN-UMIN000021969
Lead Sponsor
Hiroshima liver study group
Brief Summary

The overall SVR12 rate was 86.7% (26/30). Large decreases in mean log10 HCV RNA levels were observed in patients without cirrhosis, and the SVR12 rate for these patients was 100% (12/12). In cases of cirrhosis, SVR12 rate was 72.2%(13/18) .The common factors in treatment failure cases were the presence of liver cirrhosis and both NS5A L31M/I and Y93H RAVs. The frequency of RAVs did not change before and after treatment among patients who relapsed.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with serious renal disease(eGFR<30mL/min/1.73m2) or dialysis 2)Patients with haemoglobinopathies (thalassemia, sickle cell anemia) 3)Decompenstated liver cirrhosis 4)HCC, malignat tumor 5)Patients with Hb less than 10 g/dl. 6)Pregnant or lactating women and women who may be pregnant 7)Judged by investigator not to be appropriate for inclusion in this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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