Clinical trial NCT01995071: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Hepatitis C Virus
Compensated Cirrhosis
Keywords: Chronic Hepatitis C
Cirrhosis
Child Pugh A
Hepatitis C virus
Compensated Cirrhosis
Hepatitis C Genotype 1
Hepatitis C
Interferon-Free
Cirrhotic
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment
timeFrame: Day 1 through prior to first dose of the combination regimen on Study Day 4
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after last actual dose of combination study drug
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Up to 87 days
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: From the end of treatment through 12 weeks after the last dose of combination study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References:
citation: Lawitz E, Freilich B, Link J, German P, Mo H, Han L, Brainard DM, McNally J, Marbury T, Rodriguez-Torres M. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015 Dec;22(12):1011-9. doi: 10.1111/jvh.12435. Epub 2015 Jul 16.
citation: Lawitz EJ, O'Riordan WD, Asatryan A, Freilich BL, Box TD, Overcash JS, Lovell S, Ng TI, Liu W, Campbell A, Lin CW, Yao B, Kort J. Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1546-55. doi: 10.1128/AAC.02264-15.