Trial intelligence / Profile preview

Mavyret in Chronic HCV Genotype 1

NCT02604017Phase 3

Key facts

Status: Completed
Start: Oct 2015
Primary completion: Jan 2017
Sponsor: AbbVie Inc.
Modality: Reversible Covalent Inhibitors, Allosteric Modulators, Orthosteric Ligands

Drugs: glecaprevir
Conditions: hepatitis C (HCV)

Overview

Phase 3, randomised, open-label trial of glecaprevir in hepatitis C (HCV) (2 arms), sponsored by AbbVie Inc. Primary endpoint: Sustained Virologic Response 12 Weeks Post-treatment. Started Oct 2015; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

12-Week Arm
Mavyret for 12 weeks
8-Week Arm
Mavyret for 8 weeks

Who it enrols

Adults with chronic HCV Genotype 1 infection, without cirrhosis. Patients may be treatment-naive or treatment-experienced (IFN/pegIFN +/- RBV or SOF +/- RBV +/- pegIFN). HIV-1 co-infection is allowed if controlled.

Endpoints

Primary

Sustained Virologic Response 12 Weeks Post-treatment12 weeks post-treatment

Secondary

Percentage of Participants With On-treatment Virologic FailureTreatment Weeks 1, 2, 4, 8, 12
Percentage of Participants With Post-treatment Relapse12 weeks post-treatment

Results

Primary endpoints met

Beyond the preview

Go deeper on NCT02604017.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT02604017.