MedTrace Logo

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults

NCT01854528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2018-06-06

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267; ABT-267 also known as ombitasvir\] and ABT-333 \[also known as dasabuvir\]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Conditions

  • Chronic Hepatitis C Infection

Interventions

DRUG

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

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

DRUG

Ribavirin

Tablet

DRUG

Pegylated Interferon a-2a (PegINF)

Pre-filled syringe

DRUG

Telaprevir

Film-coated tablet

Sponsors & Collaborators

Principal Investigators

  • Yan Luo, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-11-30
Completion
2015-07-31

More Related Trials

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 NCT01854528 on ClinicalTrials.gov