November 26, 2013

This study is not yet open for participant recruitment.

Verified November 2013 by AbbVie

Sponsor: AbbVie

Information provided by (Responsible Party): AbbVie

ClinicalTrials.gov Identifier:
NCT01995071
First received: November 21, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted

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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Hepatitis A Vaccines

U.S. FDA Resources

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 87 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: 80
    Study Start Date: November 2013
    Estimated Study Completion Date: May 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 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 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 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 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 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 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 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 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 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 weeks
Drug: ABT-530
tablet
Drug: ABT-450/r/ABT-267
tablet
Drug: ABT-333
tablet
Drug: Ribavirin (RBV)
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

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

Contacts

Contact: Christian Naylor, BS
847-935-2492
christian.naylor@abbvie.com

Contact: Mary Santangelo, BS
847-938-6703
mary.santangelo@abbvie.com

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: November 21, 2013

Health Authority: United States: Food and Drug Administration

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