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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) | Clinical Trials | Clareo Health

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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)

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

NCT01995071•AbbVie

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

November 1, 2013

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

July 12, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis CHepatitis C VirusCompensated Cirrhosis

Interventions

ABT-493

DRUG

ABT-530

DRUG

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

DRUG

Ribavirin (RBV)

DRUG

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

NCT06855056

Liver CirrhosisDecompensated Cirrhosis of Liver

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RECRUITINGNA

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

NCT06431919

Decompensated CirrhosisCirrhotic Cardiomyopathy+3 more

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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 12, 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.

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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)

Inclusion Criteria

Exclusion Criteria

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

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