Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV) infection without cirrhosis.

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Detailed Description

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An open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-267 as monotherapy for 2 days, followed by ABT-267, ABT-450 with ritonavir (ABT-450/r) and ABT-333 plus ribavirin (RBV) combination therapy for 12 weeks in treatment-naïve, non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. The study included post-treatment follow-up for 48 weeks.

Conditions

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Chronic Hepatitis C Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-267 1.5 mg, then ABT-267, ABT-450/r, ABT-333, plus RBV

ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks

Group Type EXPERIMENTAL

ABT-267

Intervention Type DRUG

Tablet

ABT-450

Intervention Type DRUG

Tablet

ABT-333

Intervention Type DRUG

Tablet

Ritonavir

Intervention Type DRUG

Capsule

Ribavirin

Intervention Type DRUG

Tablet

ABT-267 25 mg, then ABT-267, ABT-450/r, ABT-333, plus RBV

ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks

Group Type EXPERIMENTAL

ABT-267

Intervention Type DRUG

Tablet

ABT-450

Intervention Type DRUG

Tablet

ABT-333

Intervention Type DRUG

Tablet

Ritonavir

Intervention Type DRUG

Capsule

Ribavirin

Intervention Type DRUG

Tablet

Interventions

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ABT-267

Tablet

Intervention Type DRUG

ABT-450

Tablet

Intervention Type DRUG

ABT-333

Tablet

Intervention Type DRUG

Ritonavir

Capsule

Intervention Type DRUG

Ribavirin

Tablet

Intervention Type DRUG

Other Intervention Names

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ombitasvir dasabuvir

Eligibility Criteria

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Inclusion Criteria

* Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.
* Subject has never received antiviral treatment for hepatitis C virus (HCV) infection.
* Body mass index (BMI) is ≥ 18 to \< 38 kg/m\^2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
* Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.
* Subject has plasma HCV RNA level \> 10,000 IU/mL at screening

Exclusion Criteria

* History of severe, life-threatening or other significant sensitivity to any drug.
* Females who are or plan to become pregnant or breastfeeding or males whose partner is pregnant or planning to become pregnant.
* Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
* Positive test result for hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibodies.
* Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal varices), or a liver biopsy or FibroTest/aspartate aminotransferase to platelet ratio (APRI) or FibroScan® showing cirrhosis or extensive bridging fibrosis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No