Phase 2
N=89
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
Chronic Hepatitis C · Hepatitis C Virus · Compensated Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT01995071 ↗Enrolled (actual)
89
Serious AEs
4.5%
Results posted
Oct 2017
Primary outcome: Primary: Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment — -4.11; -4.02; -4.31; -4.06 Log10 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ABT-493 (Drug); ABT-530 (Drug); ABT-450/r/ABT-267, ABT-333 (Drug); Ribavirin (RBV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment |
-4.11; -4.02; -4.31; -4.06; -3.38; -4.21 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
87.5; 100; 87.5; 100; 100; 100 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0; 0; 0; 0; 0; 0 | — |
Summary
The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.
Eligibility Criteria
Inclusion Criteria
- Chronic HCV infection prior to study enrollment.
- Screening laboratory result indicating HCV genotype 1-infection.
- Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.
- Per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis.
Exclusion Criteria
- History of severe, life-threatening or other significant sensitivity to any drug.
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus antibody (HIV Ab).
- Prior therapy for the treatment of HCV.
- Any current or past clinical evidence of Child Pugh B or C classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
- Any cause of liver disease other than chronic HCV infection.
Data sourced from ClinicalTrials.gov (NCT01995071). 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.