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

Completed · Phase 2

Conditions studied: Chronic Hepatitis C Infection

In brief

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.

Key facts

Study ID

NCT01563536

Run by

AbbVie (prior sponsor, Abbott)

People needed

12

Starts

2012-02-01

Expected to finish

2013-06-01

Last updated by the study team

2018-07-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 68002 — Bakersfield, California, United States
• Site Reference ID/Investigator# 67383 — Orlando, Florida, United States
• Site Reference ID/Investigator# 67382 — Annapolis, Maryland, United States
• Site Reference ID/Investigator# 67385 — Poughkeepsie, New York, United States

Full record on ClinicalTrials.gov

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