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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 8
- Primary Endpoint
- Sustained Virologic Response At 12 Weeks (SVR12)
Study Overview
Brief Summary
The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.
Detailed Description
A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females aged 18 years and older.
- •Clinical diagnosis of hepatitis C with GT1b.
- •Chronic hepatitis C treatment-naive participants.
- •Interleukin 28B genotype CC.
- •HCV ribonucleic acid > 10,000 international units/milliliter at screening.
- •Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin.
- •Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin.
- •Willing to participate in all study activities and all study requirements.
Exclusion Criteria
- •Body mass index > 36 kilograms/meter squared.
- •Pregnant or nursing females.
- •Clinically significant laboratory abnormalities at screening.
- •Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor.
- •Human immunodeficiency virus 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.
Arms & Interventions
ACH-0143102 plus ribavirin daily
ACH-0143102 loading dose (225 milligrams [mg]) on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.
Intervention: ACH-0143102 (Drug)
ACH-0143102 plus ribavirin daily
ACH-0143102 loading dose (225 milligrams [mg]) on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.
Intervention: Ribavirin (Drug)
Outcomes
Primary Outcomes
Sustained Virologic Response At 12 Weeks (SVR12)
Time Frame: 12 weeks following the last dose
To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point.
Secondary Outcomes
No secondary outcomes reported