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A Study to Evaluate Chronic Hepatitis C Infection

NCT01716585 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2021-07-12

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.

Conditions

  • Chronic Hepatitis C Infection

Interventions

DRUG

ABT-450/r/ABT-267, ABT-333

ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

DRUG

Ribavirin

Capsule (double-blind treatment period), tablet (open-label treatment period)

DRUG

Placebo for ABT-450/r/ABT-267

Tablet

DRUG

Placebo for ABT-333

Tablet

DRUG

Placebo for ribavirin

Capsule

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Nancy Shulman, MD · AbbVie

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
2012-11-30
Primary Completion
2013-10-31
Completion
2014-10-31

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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 NCT01716585 on ClinicalTrials.gov