Phase 1
Completed N=8
Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01700179 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Sustained Virologic Response At 12 Weeks (SVR12) — 50 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response At 12 Weeks (SVR12) |
50 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01700179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.