Status:
COMPLETED
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Chronic Hepatitis C
Hepatitis C (HCV)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).
Detailed Description
A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with HCV...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT01464827
Start Date
October 1 2011
End Date
September 1 2013
Last Update
April 22 2015
Active Locations (97)
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1
Site Reference ID/Investigator# 57583
Birmingham, Alabama, United States, 35209
2
Site Reference ID/Investigator# 55530
Birmingham, Alabama, United States, 35215
3
Site Reference ID/Investigator# 55385
Dothan, Alabama, United States, 36305
4
Site Reference ID/Investigator# 55500
Phoenix, Arizona, United States, 85054