Status:
COMPLETED
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
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Chronic Hepatitis C Virus Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 part...
Detailed Description
This was a Phase 2a, blinded, randomized, placebo-controlled clinical trial in hepatitis C virus (HCV)-infected adults with 2 planned sequential evaluations, Part 1 and Part 2. The study evaluated the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00851890
Start Date
March 1 2009
End Date
July 1 2009
Last Update
July 2 2018
Active Locations (8)
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1
Site Reference ID/Investigator# 16103
Anaheim, California, United States, 92801
2
Site Reference ID/Investigator# 16124
Los Angeles, California, United States, 90048
3
Site Reference ID/Investigator# 16102
Orlando, Florida, United States, 32803
4
Site Reference ID/Investigator# 16105
Baton Rouge, Louisiana, United States, 70808