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 (HCV) Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C Virus Infection

In brief

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.

Key facts

Study ID

NCT00851890

Run by

AbbVie (prior sponsor, Abbott)

People needed

30

Starts

2009-03-01

Expected to finish

2009-07-01

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…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 16103 — Anaheim, California, United States
• Site Reference ID/Investigator# 16124 — Los Angeles, California, United States
• Site Reference ID/Investigator# 16102 — Orlando, Florida, United States
• Site Reference ID/Investigator# 16105 — Baton Rouge, Louisiana, United States
• Site Reference ID/Investigator# 16106 — Chapel Hill, North Carolina, United States
• Site Reference ID/Investigator# 16107 — Dallas, Texas, United States
• Site Reference ID/Investigator# 16123 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 16182 — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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