Phase 2
Completed N=30
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Source: ClinicalTrials.gov NCT00851890 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment — -1.01; -0.78; -0.68; -0.26 log10 IU/mL — p=0.012
Summary
The purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus (HCV)-infected participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment |
-1.01; -0.78; -0.68; -0.26 | 0.012 sig |
| PRIMARY Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 |
-3.65; -3.96; -3.59; -1.37 | 0.008 sig |
| PRIMARY Maximum Plasma Concentration (Cmax) of ABT-333 |
883; 1236; 1975 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of ABT-333 |
3.80; 3.50; 3.50 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333 |
5852; 7548; 12411 | — |
| PRIMARY Serum Concentrations of Pegylated Interferon (pegIFN) |
0.00; 0.00; 0.00; 0.00; 0.70; 1.36 | — |
| PRIMARY Plasma Concentrations of Ribavirin (RBV) |
0.00; 0.00; 0.00; 0.00; 0.46; 0.61 | — |
| PRIMARY Number of Participants Having Treatment-emergent Adverse Events (AEs) |
8; 8; 8; 5; 4; 3 | — |
| SECONDARY Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit |
-3.65; -3.67; -3.24; -1.45; -3.65; -3.86 | 0.018 sig |
| SECONDARY Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment |
87.5; 87.5; 62.5; 16.7 | 0.026 sig |
| SECONDARY Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit |
37.5; 25.0; 62.5; 0.00 | 0.209 |
| SECONDARY Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit |
37.5; 0.00; 12.5; 0.00 | 0.209 |
| SECONDARY Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28 |
0; 1; 0; 1; 1; 1 | — |
| SECONDARY Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28 |
4; 4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has provided written consent.
- If female, participant is postmenopausal or surgically sterile.
- If male, must be practicing two effective methods of birth control.
- Participant is hepatitis C virus (HCV) genotype 1 with HCV ribonucleic acid levels >50,000 IU/mL.
- Participants must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment.
- Participants must have a liver biopsy with histology consistent with HCV-induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
- Condition of general good health other then HCV infection.
- Participants with a history of thyroid disease must have a thyroid stimulating hormone (TSH) value in the normal range.
Exclusion Criteria
- No prior history of receiving therapy for HCV infection.
- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV Ab).
- Pregnant or breastfeeding females or male partners of women who are pregnant.
- History of seizures or cancer.
- History of major depressive disorder within 2 years.
- Any current or past history of cirrhosis.
- Any cause of liver disease other than chronic HCV infection.
Data sourced from ClinicalTrials.gov (NCT00851890). 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.