NCT03485846

Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Naїve Patients With Chronic Hepatitis C Genotype 1b

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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. The results of this study will provide new information about treatment of patients with chronic hepatitis C genotype 1 with Narlaprevir/Ritonavir in combination with Daclatasvir during 12 weeks.

Conditions

• Chronic Hepatitis C Genotype 1b

Interventions

Type	Name	Description
DRUG	Narlaprevir	100 mg, oval shaped, concave, yellow film-coated, tablets taken as 200 mg per os daily
DRUG	Ritonavir	100 mg, tablets, taken as 100 mg per os daily
DRUG	Daclatasvir	60 mg, tablets, taken as 60 mg per os daily

Timeline

• Start date: 2017-11-27
• Primary completion: 2018-08-29
• Completion: 2018-11-21
• First posted: 2018-04-02
• Last updated: 2018-12-19

Locations

4 sites across 1 country: Russia