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Report for Clinical Trial NCT02455167

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Reversal of Hepatic Impairment by Achieving Sustained Virologic Response (SVR) With 12 Weeks of Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) in Patients With Hepatitis C Virus (HCV) Genotype 1 Infection and Early Decompensation of Cirrhosis (MELD 10 or Less)

1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV). 2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.

NCT02455167 Hepatitis C
MeSH:Hepatitis A Hepatitis C Hepatitis
HPO:Hepatitis

3 Interventions

Name: Simeprivir (SMV)

Description: Experimental Single arm study. All participants will get the same treatment.
Type: Drug
Group Labels: 1

HCV positive group

Name: Sofosbuvir (SOF)

Description: Experimental Single arm study. All participants will get the same treatment.
Type: Drug
Group Labels: 1

HCV positive group

Name: Ribavirin (RBV)

Description: Experimental Single arm study. All participants will get the same treatment.
Type: Drug
Group Labels: 1

HCV positive group


Primary Outcomes

Measure: The sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation

Time: 12 weeks

Measure: Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.

Time: 12 weeks

Purpose: Other

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 Q80K

Inclusion Criteria: 1. HCV genotype 1 infection (all subtypes and Q80K a type of mutation are allowed), and have been approved by a third party payer for the FDA-approved combination of sofosbuvir (SOF) plus ribavirin. --- Q80K ---



HPO Nodes


HPO: