A Study to Evaluate Chronic Hepatitis C Infection

AbbVie

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: Placebo for ABT-333; Drug: Placebo for ribavirin; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin; Drug: Placebo for ABT-450/r/ABT-267

Study type: Interventional

Funder types: Industry

Identifiers

NCT01716585

2012-002019-25 (EudraCT Number)

M11-646

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.

Enrollment: 636 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Positive screen for drugs or alcohol
• Significant sensitivity to any drug
• Use of contraindicated medications within 2 weeks of dosing
• Certain predefined abnormal laboratory tests
• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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636 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Ribavirin

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

Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABT-333

Drug: Placebo for ribavirin

Drug: Ribavirin

Drug: Placebo for ABT-450/r/ABT-267

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