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Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

NCT02399345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-12-12

Study results available
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Summary

This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

Conditions

  • Chronic Hepatitis C Virus (HCV Infection Genotype 1)

Interventions

DRUG

ombitasvir/paritaprevir/ritonavir, dasabuvir

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

DRUG

sofosbuvir (SOF)

tablet

DRUG

ribavirin (RBV)

tablet

Sponsors & Collaborators

Principal Investigators

  • Eric Cohen, MD · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

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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 NCT02399345 on ClinicalTrials.gov