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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: ABT-267; Drug: Ritonavir; Drug: Ribavirin; Drug: ABT-450; Drug: ABT-333

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563536

M13-386

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: ABT-333

Drug: ABT-450

Drug: Ribavirin

Drug: Ritonavir

Drug: ABT-267

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

Experimental group

Description:

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

Treatment:

Drug: ABT-333

Drug: ABT-450

Drug: Ribavirin

Drug: Ritonavir

Drug: ABT-267