Home
Clinical Trials
A Study to Evaluate the Effic...

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection

Last Updated: 2021-07-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

694 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-19

Study Completion Date

2017-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection

NCT02243280

Chronic Hepatitis C Hepatitis C Virus HCV

COMPLETED PHASE2

A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

NCT02068222

Chronic Hepatitis C Hepatitis C Virus

COMPLETED PHASE2

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

NCT02446717

Chronic Hepatitis C Hepatitis C Virus HCV +1 more

COMPLETED PHASE2/PHASE3

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)

NCT01995071

Chronic Hepatitis C Hepatitis C Virus Compensated Cirrhosis

COMPLETED PHASE2

A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)

NCT02738138

Hepatitis C Virus Infection Human Immunodeficiency Virus Infection Chronic Hepatitis C +1 more

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study consisted of four independent parts with treatment and post-treatment periods of enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1 and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C Hepatitis C Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm B

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm C

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm D

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm E

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm F

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm G

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm H

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm I

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm J

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm K

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm L

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm M

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm N

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm O

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

Arm P

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

Tablet

ABT-530

Intervention Type DRUG

Tablet

ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm Q1

ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 co-formulated ABT-530

Arm Q2

ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 co-formulated ABT-530

Arm R1

ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 co-formulated ABT-530

Arm R2

ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 co-formulated ABT-530

Arm S1

ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 co-formulated ABT-530

Arm S2

ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 co-formulated ABT-530

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT-493

Tablet

Intervention Type DRUG

ABT-530

Tablet

Intervention Type DRUG

ribavirin (RBV)

Tablet

Intervention Type DRUG

ABT-493/ABT-530

Tablet; ABT-493 co-formulated ABT-530

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

glecaprevir pibrentasvir ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
* Chronic HCV infection.
* Participant had to be either HCV treatment-naïve or treatment-experienced.
* Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion Criteria

* History of severe, life-threatening or other significant sensitivity to any drug.
* Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
* HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers