Overview

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus (HCV)-infected participants.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Antiviral Agents
Interferons
Ribavirin
Criteria
Inclusion Criteria:

- Participant has provided written consent.

- If female, participant is postmenopausal or surgically sterile.

- If male, must be practicing two effective methods of birth control.

- Participant is hepatitis C virus (HCV) genotype 1 with HCV ribonucleic acid levels
>50,000 IU/mL.

- Participants must demonstrate chronic hepatitis C infection for at least 6 months
prior to study enrollment.

- Participants must have a liver biopsy with histology consistent with HCV-induced liver
damage, and with no evidence of cirrhosis or liver pathology due to any cause other
than chronic HCV.

- Condition of general good health other then HCV infection.

- Participants with a history of thyroid disease must have a thyroid stimulating hormone
(TSH) value in the normal range.

Exclusion Criteria:

- No prior history of receiving therapy for HCV infection.

- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV Ab).

- Pregnant or breastfeeding females or male partners of women who are pregnant.

- History of seizures or cancer.

- History of major depressive disorder within 2 years.

- Any current or past history of cirrhosis.

- Any cause of liver disease other than chronic HCV infection.