Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 3/30/2013 |
| Start Date: | September 2012 |
| End Date: | November 2013 |
| Contact: | Lacy Reese |
| Email: | Lacy.Reese@duke.edu |
| Phone: | 919-668-8465 |
A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b.
ACH-0143102 plus ribavirin will lower viral load in hepatitis C genotype 1b treatment naive
subjects.
A phase 1b, pilot study to evaluate the safety, tolerability and antiviral activity of oral
ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment naive
subjects with chronic hepatitis C virus infection genotype 1b.
Inclusion Criteria:
- Clinical diagnosis of Hepatitis C with genotype 1b
- Chronic hepatitis C treatment naive subjects
Exclusion Criteria:
- BMI>36
- pregnant or nursing females
- clinically significant laboratory abnormalities at screening
- previous participation in a clinical trial with protease inhibitor and/or NS5A
inhibitor
- HIV infection or other liver diseases
- Positive Hepatitis B Surface Antigen
- Liver cirrhosis
- uncontrolled psychiatric disease
- clinical evidence of chronic cardiac disease
- history of malignancy of any organ system within 5 years
We found this trial at
6
sites
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