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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 12Secondary Outcomes
Measure: Proportion of subjects with anemia on active Dual therapy Time: Post-treatment Week 12Measure: 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.