A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/27/2013 |
| Start Date: | November 2012 |
| End Date: | October 2014 |
| Contact: | Melanie Gloria, BS |
| Email: | melanie.gloria@abbvie.com |
| Phone: | 847-936-0714 |
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)
A study to evaluate chronic hepatitis C infection.
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and
ABT-267 (ABT-450/r/ABT-267) and ABT-333 co-administered with ribavirin in hepatitis C virus
genotype 1 infected treatment-experienced adults (SAPPHIRE-II).
Inclusion Criteria:
- 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, genotype 1 infection (HCV RNA level greater than 10,000 IU/mL at
screening).
- Failed previous treatment with pegIFN and RBV.
- No evidence of liver cirrhosis.
Exclusion Criteria:
- Positive screen for drugs or alcohol.
- Significant sensitivity to any drug.
- Use of contraindicated medications within 2 weeks of dosing.
- Abnormal laboratory tests.
- Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody.
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