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

NCT03485846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2018-12-19

No results posted yet for this study

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.

Conditions

  • Chronic Hepatitis C Genotype 1b

Interventions

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

Sponsors & Collaborators

  • Almedis

    collaborator INDUSTRY

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2018-08-29
Completion
2018-11-21

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03485846 on ClinicalTrials.gov