Post-marketing, prospective and non-randomized trial regarding to daclatasvir and asunaprevir combination therapy for chronic liver disease with genotype 1 hepatitis C virus

Not Applicable

• Conditions: Chronic liver disease with hepatitis C virus (chronic hepatitis and compensated cirrhosis)

• Registration Number: JPRN-UMIN000025487
• Lead Sponsor: Iwate medical university

Brief Summary

The undetectable rate of HCV RNA 24 weeks after the end or stop of treatment was 90.6%. During the treatment, adverse effects were seen in 123 patients. The most frequent adverse effect was elevation of transaminase. There was no difference in rate of sustained viral response or frequency of adverse effect between non-elderly and elderly patients. Conclusions: Efficacy and safety during DCV and ASV combination therapy for elderly patients were similar to non-elderly patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-06
• Study Start: 2017-01-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Not provided

Exclusion Criteria

Previously treatment with daclatasvir and asnaprevir or other NS5A replication complex inhibitor. Decompensated cirrhosis (i.e.Child Pugh grade B or C cirrhosis). Untreated variceal hemorrhage, hepatic encephalopathy or uncontrollable ascites. HBs antigen and or human immunodeficiency virus antibody are positive. Current hepatocellular carcinoma diagnosed by US, CT or MRI(=<1 year from enrollment). Severe or uncontrolled disorder (i.e. myocardial infarction, heart failure, arrhythmia, cerebral infarction). Gastrointestinal disorder that could interfere with the absorption of the study drugs. Significant drug allergy (such as anaphylaxis or hepatotoxicitys). Advanced cancer untreated or during treatment. History of organ implantation.Findings of organ failure or unstableorgan functio. Woman in pregnancy or having a possibility that she may be in pregnancy, in nursing. Woman having a possibility of fertility or male whose partner has a possibility of fertility cannot use birth control between first treatment day and 6 months after treatment. Man whose partner is in pregnancy cannot use condom between first treatment day and 6 months after treatment. Abnormality in following laboratory tests: AST>5 times UNV, Total bilirubin>=5 mg/dL, Albumin>3 g/dL, Platelet=<50000/mm^3. Patient taking an incompatible drug. Patient restricted by legal reason. Unsuitable case judged by doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of sustained virological response (SVR) 24 weeks after end of treatment (EoT).

Secondary Outcome Measures

Name	Time	Method
Disappeared rate of HCV RNA during the treatment, EoT and SVR12. Frequency of adverse effects (grade 3 and over) Fasting glucose, insulin, HOMA-IR before and after treatment