A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection (PEARL-IV)

AbbVie

Status and phase

Completed

Phase 3

Conditions

Chronic Hepatitis C Infection

Treatments

Drug: Placebo for Ribavirin

Drug: Ribavirin

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01833533

2012-005522-29 (EudraCT Number)

M14-002

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.

Full description

A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naive, noncirrhotic participants with chronic hepatitis C virus genotype 1a (HCV GT1a) infection.

Enrollment

305 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
Subject has never received antiviral treatment for hepatitis C infection
No evidence of liver cirrhosis

Exclusion criteria

Significant liver disease with any cause other than HCV as the primary cause
Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
Positive screen for drugs or alcohol
Significant sensitivity to any drug
Use of contraindicated medications within 2 weeks of dosing
Abnormal laboratory tests

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

305 participants in 2 patient groups

ABT-450/r/ABT-267 and ABT-333, Plus RBV

Experimental group

Description:

ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Treatment:

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

Drug: Ribavirin

ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV

Experimental group

Description:

ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks

Treatment:

Drug: Placebo for Ribavirin

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