Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

A Randomized, Open-Label, Multicenter 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 (SURVEYOR-II)

NCT02243293•AbbVie

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

September 19, 2014

Primary Completion Date

October 25, 2016

Completion Date

February 23, 2017

Last Updated

July 30, 2021

Enrollment

694

ACTUAL participants

Conditions

Chronic Hepatitis CHepatitis C Virus

Interventions

ABT-493

DRUG

ABT-530

DRUG

ribavirin (RBV)

DRUG

ABT-493/ABT-530

DRUG

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

NCT05361603

Hepatitis CTransmission, Intravenous Drug Abuser+3 more

View study

ACTIVE_NOT_RECRUITINGPHASE3

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

NCT06868264

HEPATITIS C VIRUS CHRONIC INFECTION

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital