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)

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Compensated Cirrhosis Digestive System Diseases Disease Attributes Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C Virus Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-493

Drug

Tablet

Other names: glecaprevir

ABT-530

Drug

Tablet

Other names: pibrentasvir

ABT-450/r/ABT-267, ABT-333

Drug

Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Other names: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ABT-333 also known as dasabuvir, Viekira PAK

ribavirin (RBV)

Drug

Tablet

Primary outcomes

Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment

Time frame: Day 1 through prior to first dose of the combination regimen on Study Day 4

Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1.

Secondary outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Time frame: 12 weeks after last actual dose of combination study drug

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of combination study drug.
Percentage of Participants With On-treatment Virologic Failure

Time frame: Up to 87 days

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment.
Percentage of Participants With Post-treatment Relapse

Time frame: From the end of treatment through 12 weeks after the last dose of combination study drug

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Nov 26, 2013
Registry last updated: Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed