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Report for Clinical Trial NCT02473211

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection

For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.

NCT02473211 Chronic Hepatitis C Infection
MeSH:Infection Hepatitis C Hepatitis C, Chronic

2 Interventions

Name: Sofosbuvir

Description: Sofosbuvir 400 mg tablet administered once daily
Type: Drug
Group Labels: 1

SOF+DCV

Name: Daclatasvir

Description: Daclatasvir 60mg tablet administered once daily
Type: Drug
Group Labels: 1

SOF+DCV

Primary Outcomes

Description: SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug

Measure: Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)

Time: Post treatment Week 12
Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP

SNPs

1 rs12979860

At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined.


HPO Nodes