SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01573351

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection

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
MeSH:Hepatitis C Hepatitis
HPO:Hepatitis

4 Interventions

Name: Asunaprevir

Type: Drug
Group Labels: 1

QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Name: Daclatasvir

Type: Drug
Group Labels: 1

QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Name: Peg-interferon Alfa-2a

Type: Drug
Group Labels: 1

QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Name: Ribavirin

Type: Drug
Group Labels: 1

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

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 rs12979860

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


HPO: