Phase 3
Completed N=146
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
Source: ClinicalTrials.gov NCT02642432 ↗Enrolled (actual)
146
Serious AEs
7.5%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 99.3 percentage of participants
◆ Published Evidence
Established
▲ Trending
39citations · ~6 / year
Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies.
Summary
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
Linked Publications (5)
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Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies.
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Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease.
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Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials.
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Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis.
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Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
99.3 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
- Chronic HCV infection
- Subject must be HCV treatment-naïve or have failed prior HCV treatment
- Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease
Exclusion Criteria
- Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
- HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530
Data sourced from ClinicalTrials.gov (NCT02642432) and the linked publication. 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.