SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01797848

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4

The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects

NCT01797848 Hepatitis C
MeSH:Hepatitis C Hepatitis
HPO:Hepatitis

4 Interventions

Name: Peginterferon alfa 2a

Type: Drug
Group Labels: 2

pegIFNα 2a + Ribavirin + Daclatasvir pegIFNα 2a + Ribavirin + Placebo

Name: Ribavirin

Type: Drug
Group Labels: 2

pegIFNα 2a + Ribavirin + Daclatasvir pegIFNα 2a + Ribavirin + Placebo

Name: Placebo matching Daclatasvir

Type: Drug
Group Labels: 1

pegIFNα 2a + Ribavirin + Placebo

Name: Daclatasvir

Type: Drug
Group Labels: 1

pegIFNα 2a + Ribavirin + Daclatasvir


Primary Outcomes

Measure: Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort

Time: Week 24 post treatment follow up

Secondary Outcomes

Measure: Proportion of Genotype (GT) 4 subjects with SVR24

Time: Week 24 post treatment follow up visit

Measure: Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable

Time: Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)

Measure: Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)

Time: Up to 48 weeks plus 30 days

Measure: Discontinuations due to Adverse Events (AEs)

Time: Up to 48 weeks plus 7 days

Measure: Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene

Time: Up to 72 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene.



HPO Nodes


HPO: