Trial intelligence / Profile preview

ABT-450/r + ABT-072 + Ribavirin in HCV Genotype 1

NCT01221298Phase 2

Key facts

Status: Completed
Start: Oct 2010
Primary completion: May 2011
Countries: 1
Sponsor: AbbVie Inc.
Modality: Allosteric Modulators, Orthosteric Ligands

Drugs: paritaprevirABT-072
Conditions: hepatitis C (HCV)

Overview

Phase 2, open-label, single-arm trial of paritaprevir and ABT-072 in hepatitis C (HCV), sponsored by AbbVie Inc. Primary endpoint: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12. Started Oct 2010; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

ABT-450/r + ABT-072 + RBV
ABT-450/r (150/100 mg) QD + ABT-072 (400 mg) QD + Ribavirin BID

Who it enrols

Treatment-naive adults with chronic HCV genotype 1 infection, IL28B CC genotype, and no cirrhosis.

Endpoints

Primary

Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12Week 12

Secondary

Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)Week 2
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4Week 4
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment12 weeks post-treatment
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment24 weeks post-treatment
Time to Failure to Suppress or Rebound During TreatmentWeek 12
Time to Virologic Relapse Through 24 Weeks Post-treatment24 weeks post-treatment

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