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Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

NCT02023099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2018-06-06

Study results available
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Summary

This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.

Conditions

  • Chronic Hepatitis C Infection

Interventions

DRUG

ABT-450/r/ABT-267

Tablet; ABT-450 coformulated with ritonavir and ABT-267

DRUG

Placebo

Tablet

Sponsors & Collaborators

Principal Investigators

  • Nori Yachi · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-10-31
Completion
2015-10-31

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Entities

Drugs
Companies

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 NCT02023099 on ClinicalTrials.gov