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Report for Clinical Trial NCT02496078

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.

NCT02496078 Hepatitis C
MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis

2 Interventions

Name: Daclatasvir

Description: Daclatasvir tablet 60mg
Type: Drug
Group Labels: 2

Active dual arm Placebo arm

Name: Asunaprevir

Description: Asunaprevir soft capsule 100 mg
Type: Drug
Group Labels: 2

Active dual arm Placebo arm


Primary Outcomes

Description: HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12

Measure: Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)

Time: Post-treatment Week 12

Secondary Outcomes

Measure: Proportion of subjects with anemia on active Dual therapy

Time: Post-treatment Week 12

Measure: Proportion of subjects with neutropenia on active Dual therapy

Time: Post-treatment Week 12

Measure: Proportion of subjects with thrombocytopenia on active Dual therapy

Time: Post-treatment Week 12

Measure: On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

Time: Post-treatment week 12

Measure: Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)

Time: first 12 weeks on treatment

Measure: Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)

Time: first 12 weeks on treatment

Measure: Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort

Time: Post-treatment visit week 12

Measure: Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy

Time: post-treatment visit Week 24

Measure: Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy

Time: post-treatment visit Week 24

Measure: Proportion of treated subjects with SVR12 for subjects randomized to placebo

Time: Post-treatment visit week 12

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs12979860

Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort.



HPO Nodes


HPO: