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)

Phase 2CompletedNCT01995071

AbbVie89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Hepatitis C Virus Compensated Cirrhosis

Interventions

ABT-493DRUG

Tablet

ABT-530DRUG

Tablet

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

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

Ribavirin (RBV)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

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

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.

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

Percentage of Participants With On-treatment Virologic Failure

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.

Time frame: Up to 87 days

Percentage of Participants With Post-treatment Relapse

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.

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

Data from ClinicalTrials.gov

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