An Open-Label 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) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
Brief 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.
Detailed Description
This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
ABT-450/r and ABT-072, plus ribavirin (RBV)
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Intervention: ABT-450 (Drug)
ABT-450/r and ABT-072, plus ribavirin (RBV)
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Intervention: ABT-072 (Drug)
ABT-450/r and ABT-072, plus ribavirin (RBV)
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Intervention: Ribavirin (Drug)
ABT-450/r and ABT-072, plus ribavirin (RBV)
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Intervention: Ritonavir (Drug)
Outcomes
Primary Outcomes
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
Time Frame: Week 4 through Week 12
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).
Secondary Outcomes
- Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)(Week 2)
- Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4(Week 4)
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment(Post-treatment Day 1 to Post-treatment Week 12)
- Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment(Post-treatment Day 1 to Post-treatment Week 24)
- Time to Failure to Suppress or Rebound During Treatment(Day 1 through Week 12)
- Time to Virologic Relapse Through 24 Weeks Post-treatment(Post-treatment Day 1 to Post-treatment Week 24)