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Efficacy and Safety of Narlaprevir Used in Combination With Ritonavir in Treatment-Naïve and Failed Prior Treatment With Pegylated Interferon/Ribavirin Patients With Chronic Hepatitis C Genotype 1 (PIONEER - Study)

NCT03833362 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2019-02-07

No results posted yet for this study

Summary

The purpose of this study was to confirm that combination of narlaprevir (NVR) and ritonavir (RTV) used as a metabolic inhibitor with pegylated interferon (PEG-INF) and ribavirin (RBV) leads to a superior Sustained Virological Response (SVR) rate compared to treatment with pegylated interferon and ribavirin in treatment-naïve and treatment failure patient populations.

Conditions

  • Hepatitis C

Interventions

DRUG

Narlaprevir

yellow film-coated 100 mg. tablets

DRUG

Ritonavir

100 mg tablets encapsulates in gelatin capsules (for blinding purposes)

DRUG

Placebo Narlaprevir

yellow film-coated 100 mg. tablets identical to Narlaprevir tablets

DRUG

Placebo Ritonavir

100 mg lactose/ cellulose tablets encapsulated in gelatin capsules (for blinding purposes) identical to Ritonavir capsules

DRUG

Pegylated interferon alfa-2a/ Pegylated interferon alfa-2b

180µg for subcutaneous injections in 0.5 ml syrettes / 1.5 µg/kg for subcutaneous injections in 50µkg, 80µkg,100µkg, 120µkg, 150µkg in vials

DRUG

Ribavirin

hard gelatin, white 200mg. capsules Weight-based dose was 1000 mg/day (patient weight \<75 kg) or 1200 mg/day (patient weight ≥75 kg) with Peginterferon alfa-2a and 800 mg/day (patient weight \<65 kg) - 1400 (patient weight \>105 kg) mg/day with Peginterferon alfa-2b

Sponsors & Collaborators

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-07
Primary Completion
2016-03-23
Completion
2017-02-21

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 NCT03833362 on ClinicalTrials.gov