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A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

NCT01074008 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-01-08

Study results available
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Summary

This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.

Conditions

  • Hepatitis C
  • HCV
  • Chronic Hepatitis C Infection
  • Hepatitis C Genotype 1

Interventions

DRUG

ABT-450

50 mg capsules co-administered with ritonavir

DRUG

ABT-072

50 mg tablet

DRUG

ABT-333

400 mg tablet

DRUG

Ritonavir

100 mg capsules co-administered with ABT-450

DRUG

Peginterferon alpha-2a

Syringe, 180 µg/0.5 mL for subcutaneous injections

DRUG

Ribavirin

200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day

OTHER

Placebo

Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Daniel Cohen · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-06-30
Completion
2012-01-31

Countries

  • United States
  • Puerto Rico

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 NCT01074008 on ClinicalTrials.gov