Multicenter, Open-label, Phase II Safety and Efficacy Study of All-oral Combination Narlaprevir/Ritonavir and Daclatasvir Administered for 12 Weeks in Patients With Genotype 1b Chronic Hepatitis C
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 105
- Locations
- 4
- Primary Endpoint
- The proportion of patients achieved Sustained Virologic Response (SVR12)
Study Overview
Brief Summary
The purpose of this study is to confirm that combination of Narlaprevir, Ritonavir and Daclatasvir is safe and highly effective regimen in treatment-naїve patients with chronic hepatitis C (HCV) genotype 1b infection.
Detailed Description
To evaluate effectiveness and safety of treatment with Narlaprevir, Ritonavir and Daclatasvir combination will be selected 105 treatment-naїve patients with chronic HCV genotype 1b without genetic variants coding for the NS5A-Y93 С/H/N/S and/or L31 F/M/V/I amino acid substitutions, eligible as per protocol criteria.
Each patient will participate in the trial approximately up to 38 weeks:
- 2 weeks are expected for screening
- up to 12 weeks for treatment period
- 24 weeks for follow-up period
During treatment period all patient will receive equal drug combination.
Efficacy and safety parameters will be assessed as per primary and secondary endpoints. Also Ctrough for Narlaprevir and Daclatasvir on day 14 will be evaluated as pharmacokinetic objective.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Narlaprevir + Ritonavir + Daclatasvir
All of enrolled patients receive equal study therapy with Narlaprevir/Ritonavir/Daclatasvir daily for 12 weeks
Intervention: Narlaprevir (Drug)
Narlaprevir + Ritonavir + Daclatasvir
All of enrolled patients receive equal study therapy with Narlaprevir/Ritonavir/Daclatasvir daily for 12 weeks
Intervention: Ritonavir (Drug)
Narlaprevir + Ritonavir + Daclatasvir
All of enrolled patients receive equal study therapy with Narlaprevir/Ritonavir/Daclatasvir daily for 12 weeks
Intervention: Daclatasvir (Drug)
Outcomes
Primary Outcomes
The proportion of patients achieved Sustained Virologic Response (SVR12)
Time Frame: Week 12 of follow-up period
SVR12 - Undetectable HCV RNA by lower limit of detection (LOD) 12 weeks following the end of treatment
Secondary Outcomes
- The proportion of patients achieved End of Treatment Response (ETR)(Week 12 of treatment)
- The proportion of patients Relapsed(Week 12 of follow-up period)
- The proportion of patients achieved Sustained Virologic Response (SVR24)(Week 24 of follow-up period)
- The proportion of patients achieved Sustained Virologic Response (SVR4)(Week 4 of follow-up period)
- The proportion of patients developed Viral Breakthrough(Week 12 of treatment)