ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

Completed · Phase 2

Conditions studied: Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1

In brief

This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

Key facts

Study ID

NCT01464827

Run by

AbbVie (prior sponsor, Abbott)

People needed

580

Starts

2011-10-01

Expected to finish

2013-09-01

Last updated by the study team

2015-04-22

Who can join

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

You may qualify if…

• Males and females 18-70 years old, inclusive
• Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
• Chronic hepatitis C virus (HCV), genotype 1 infection
• Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12)
• No evidence of liver cirrhosis

You may not qualify if…

• Significant liver disease with any cause other than HCV as the primary cause
• Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody
• Positive screen for drugs and alcohol
• Significant sensitivity to any drug
• Use of contraindicated or prohibited medications within 1 month of dosing
• Abnormal laboratory tests

Where it is running

• Site Reference ID/Investigator# 55530 — Birmingham, Alabama, United States
• Site Reference ID/Investigator# 55385 — Dothan, Alabama, United States
• Site Reference ID/Investigator# 55500 — Phoenix, Arizona, United States
• Site Reference ID/Investigator# 55382 — Tucson, Arizona, United States
• Site Reference ID/Investigator# 61042 — Bakersfield, California, United States
• Site Reference ID/Investigator# 43651 — Coronado, California, United States
• Site Reference ID/Investigator# 43652 — Costa Mesa, California, United States
• Site Reference ID/Investigator# 59130 — Los Angeles, California, United States
• Site Reference ID/Investigator# 43565 — San Diego, California, United States
• Site Reference ID/Investigator# 43910 — Aurora, Colorado, United States
• Site Reference ID/Investigator# 43572 — Bradenton, Florida, United States
• Site Reference ID/Investigator# 43584 — Ft. Pierce, Florida, United States
• Site Reference ID/Investigator# 43917 — Gainesville, Florida, United States
• Site Reference ID/Investigator# 55384 — Jacksonville, Florida, United States
• Site Reference ID/Investigator# 44610 — Wellington, Florida, United States
• Site Reference ID/Investigator# 55531 — Wellington, Florida, United States
• Site Reference ID/Investigator# 55536 — Zephyrhills, Florida, United States
• Site Reference ID/Investigator# 55540 — Macon, Georgia, United States
• Site Reference ID/Investigator# 55527 — Marietta, Georgia, United States
• Site Reference ID/Investigator# 44621 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 43576 — Indianapolis, Indiana, United States
• Site Reference ID/Investigator# 55383 — Bowling Green, Kentucky, United States
• Site Reference ID/Investigator# 59124 — Shreveport, Louisiana, United States
• Site Reference ID/Investigator# 43568 — Annapolis, Maryland, United States
• Site Reference ID/Investigator# 57583 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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