Status:
COMPLETED
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and A...
Detailed Description
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and...
Eligibility Criteria
Inclusion
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
- Subject has never received antiviral treatment for hepatitis C infection
- No evidence of liver cirrhosis
Exclusion
- Significant liver disease with any cause other than HCV as the primary cause
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- Positive screen for drugs or alcohol
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT01833533
Start Date
March 1 2013
End Date
September 1 2014
Last Update
July 12 2021
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