SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02473211

Developed by Shray Alag, 2019.
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, Chronic Hepatitis C, Chronic
HPO: Chronic active hepatitis Chronic hepatitis

2 Interventions

Name: Sofosbuvir

Description: Sofosbuvir 400 mg tablet administered once daily

Type: Drug

SOF+DCV

Name: Daclatasvir

Description: Daclatasvir 60mg tablet administered once daily

Type: Drug

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

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


HPO:
Chronic active hepatitis
Genes 5
KRT8 ALMS1 C4B KRT18 AIRE
Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG