SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01573351
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The purpose of this study is to assess efficacy, as determined by the proportion of subjects
with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C
virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.
NCT01573351 Hepatitis C Virus
4 Interventions
Name: Asunaprevir
Type: Drug
QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin
Name: Daclatasvir
Type: Drug
QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin
Name: Peg-interferon Alfa-2a
Type: Drug
QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin
Name: Ribavirin
Type: Drug
QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin
Primary Outcomes
Measure: Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1
Time: At 12 weeks post-treatment
Secondary Outcomes
Measure: On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment
Time: Through the end of treatment (maximum up to 24 weeks) plus 7 days
Measure: Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene
Time: At post-treatment Week 12
Measure: Proportion of subjects with HCV RNA undetectable
Time: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24
Measure: Proportion of subjects with HCV RNA < LOQ
Time: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24)
Measure: Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects
Time: Post-treatment Week 12
Purpose: Treatment
Single Group Assignment
There is one SNP
SNPs
Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene.
HPO Nodes