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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma

NCT02504099 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-12-12

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

Conditions

  • Chronic Hepatitis C Infection

Interventions

DRUG

ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

DRUG

ombitasvir/paritaprevir/ritonavir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

DRUG

ribavirin

Tablet

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-09-30
Completion
2016-12-31

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Entities

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 NCT02504099 on ClinicalTrials.gov