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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 Genotype 2 Chronic Hepatitis C Virus (HCV) Infection

NCT02023112 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2021-07-30

Study results available
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Summary

This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.

Conditions

  • Hepatitis C Virus

Interventions

DRUG

ABT-450/r/ABT-267

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

DRUG

Ribavirin

Capsule

Sponsors & Collaborators

Principal Investigators

  • Yasunori Yachi · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-04-30
Completion
2015-09-30

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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 NCT02023112 on ClinicalTrials.gov