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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01995071
First received: November 21, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Hepatitis C Virus
Compensated Cirrhosis
Drug: ABT-493
Drug: ABT-530
Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin (RBV)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Maximal decrease in log10 hepatitis C virus ribonucleic acid levels from baseline [ Time Frame: 3 days after first dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of subjects with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification

  • The percentage of subjects with on-treatment virologic failure during the treatment period [ Time Frame: Up to 171 days ] [ Designated as safety issue: No ]
    Percentage of subjects with quantifiable hepatitis C virus ribonucleic acid throughout the entire treatment period, confirmed quantifiable hepatitis C virus ribonucleic acid after previously having unquantifiable hepatitis C virus ribonucleic acid, or a confirmed increase of at least one log10 in hepatitis C virus ribonucleic acid during treatment

  • The percentage of subjects with post-treatment relapse [ Time Frame: Within 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    Percentage of subjects with confirmed quantifiable hepatitis C virus ribonucleic acid among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment


Estimated Enrollment: 96
Study Start Date: November 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
ABT-493 Dose A for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-493
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 2
ABT-493 Dose B for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-493
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 3
ABT-493 Dose C for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-493
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 4
ABT-493 Dose D for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-493
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 5
ABT-493 Dose E for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-493
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 6
ABT-530 Dose A for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-530
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 7
ABT-530 Dose B for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-530
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 8
ABT-530 Dose C for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-530
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 9
ABT-530 Dose D for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-530
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 10
ABT-530 Dose E for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-530
tablet
Experimental: Arm 11
ABT-493 Dose F for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-493
tablet
Experimental: Arm 12
ABT-530 Dose F for 3 days, followed by ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-530
tablet

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995071

Locations
United States, Arizona
Site Reference ID/Investigator# 119692
Phoenix, Arizona, United States, 85054
United States, California
Site Reference ID/Investigator# 120958
Chula Vista, California, United States, 91911
Site Reference ID/Investigator# 123766
Rialto, California, United States, 92377
Site Reference ID/Investigator# 123058
San Diego, California, United States, 92120
Site Reference ID/Investigator# 120956
San Diego, California, United States, 92120
Site Reference ID/Investigator# 120955
San Diego, California, United States, 92120
Site Reference ID/Investigator# 119719
San Diego, California, United States, 92161
United States, Colorado
Site Reference ID/Investigator# 119680
Aurora, Colorado, United States, 80045
United States, Florida
Site Reference ID/Investigator# 119687
Orlando, Florida, United States, 32809
Site Reference ID/Investigator# 119678
Orlando, Florida, United States, 32803
United States, Georgia
Site Reference ID/Investigator# 119695
Atlanta, Georgia, United States, 30308
United States, Indiana
Site Reference ID/Investigator# 119685
Indianapolis, Indiana, United States, 46202-5121
United States, Maryland
Site Reference ID/Investigator# 119691
Baltimore, Maryland, United States, 21202
United States, Missouri
Site Reference ID/Investigator# 123765
Kansas City, Missouri, United States, 64131
United States, New York
Site Reference ID/Investigator# 119690
New York, New York, United States, 10016
United States, Texas
Site Reference ID/Investigator# 119686
San Antonio, Texas, United States, 78215
United States, Utah
Site Reference ID/Investigator# 119677
Murray, Utah, United States, 84123
United States, Washington
Site Reference ID/Investigator# 119683
Seattle, Washington, United States, 98101
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Armen Asatryan, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01995071     History of Changes
Other Study ID Numbers: M13-595
Study First Received: November 21, 2013
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Chronic Hepatitis C
Cirrhosis
Child Pugh A
Hepatitis C virus
Compensated Cirrhosis
Hepatitis C Genotype 1
Hepatitis C
Interferon-Free
Cirrhotic

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Cirrhosis
Virus Diseases
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014