Phase 2
Completed N=11
A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)
Hepatitis C · HCV · Chronic Hepatitis C Infection · Hepatitis C Genotype 1
Source: ClinicalTrials.gov NCT01221298 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 — 100 percentage of participants
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 |
100 | — |
| SECONDARY Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) |
100 | — |
| SECONDARY Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 |
100 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment |
90.9 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment |
90.9 | — |
| SECONDARY Time to Failure to Suppress or Rebound During Treatment |
NA | — |
| SECONDARY Time to Virologic Relapse Through 24 Weeks Post-treatment |
84 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C.
- Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
- Treatment naïve male or female between the ages of 18 and 65.
- Females must be postmenopausal for at least 2 years or surgically sterile.
- Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
- Body mass index 18 to < 35 kg/m^2 .
Exclusion Criteria
- Significant sensitivity to any drug.
- Use of herbal supplements within 2 weeks prior to study drug dosing.
- Positive screen for certain drugs or alcohol.
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
- Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
- Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
- Abnormal laboratory tests.
- Cirrhosis or extensive bridging fibrosis.
- History of cardiac disease.
Data sourced from ClinicalTrials.gov (NCT01221298). 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.