Trial intelligence / Profile preview

AGATE-II: Technivie + Ribavirin in Egyptian HCV GT4

NCT02247401Phase 3

Key facts

Status: Completed
Start: Nov 2014
Primary completion: Aug 2016
Sponsor: AbbVie Inc.
Modality: Small Molecules

Drugs: ombitasvir + paritaprevir + ritonavir
Conditions: chronic hepatitis C (CHC)

Overview

Phase 3, randomised, open-label trial of ombitasvir + paritaprevir + ritonavir in chronic hepatitis C (CHC) (3 arms), sponsored by AbbVie Inc. Primary endpoints: Sustained Virologic Response 12 Weeks Post-treatment and Number of Participants With Adverse Events. Started Nov 2014; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Non-cirrhotic
Technivie + RBV for 12 weeks
Cirrhotic 12w
Technivie + RBV for 12 weeks
Cirrhotic 24w
Technivie + RBV for 24 weeks

Who it enrols

Adults with chronic HCV genotype 4 infection, treatment-naive or treatment-experienced (PegIFN/RBV), with or without compensated cirrhosis (Child-Pugh A).

Endpoints

Primary

Sustained Virologic Response 12 Weeks Post-treatment12 weeks post-treatment
Number of Participants With Adverse EventsScreening to 30 days post-treatment

Secondary

Percentage of Participants With On-treatment Virologic FailureUp to 24 weeks
Percentage of Participants With Post-treatment RelapseUp to 12 weeks post-treatment

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