A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

Last updated: July 9, 2021
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Hepatitis

Liver Disorders

Hiv

Treatment

N/A

Clinical Study ID

NCT02640157
M13-594
2015-002272-24
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female (of nonchildbearing potential, practicing total abstinence, sexuallyactive with female partners only, or using allowed contraceptive methods) at least 18years of age at time of screening.
  • Screening laboratory result indicating HCV GT3 infection.
  • Chronic HCV infection, defined as one of the following:
  • Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months beforescreening; or
  • A liver biopsy consistent with chronic HCV infection; or
  • Abnormal alanine aminotransferase (ALT) levels for at least 6 months beforescreening.
  • Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCVtreatment).
  • Documented as noncirrhotic.

Exclusion

Exclusion Criteria:

  • Female who was pregnant, planning to become pregnant during the study, orbreastfeeding; or male whose partner was pregnant or planning to become pregnantduring the study.
  • Recent (within 6 months prior to study drug administration) history of drug or alcoholabuse that could have precluded adherence to the protocol in the opinion of theinvestigator.
  • Positive test result at screening for hepatitis B surface antigen (HBsAg) oranti-human immunodeficiency virus Ab (HIV Ab).
  • Hepatitis C virus genotyping performed during screening indicated co-infection withmore than one HCV genotype.
  • Any cause of liver disease other than chronic HCV infection.
  • Consideration by the investigator, for any reason, that the participant was anunsuitable candidate to receive ABT-493/ABT-530, SOF, or DCV.
  • History of severe, life-threatening, or other significant sensitivity to anyexcipients of the study drug.
  • Previous use of any anti-HCV treatment.

Study Design

Total Participants: 506
Study Start date:
December 01, 2015
Estimated Completion Date:
February 28, 2017

Study Description

This study was a Phase 3, randomized, open-label, active-controlled multicenter study to compare efficacy and safety of ABT-493/ABT-530 to SOF and DCV in treatment-naïve chronic HCV GT3-infected participants without cirrhosis. The study consisted of 2 periods, a treatment period (participants received 8 or 12 weeks of ABT-493/ABT-530 or 12 weeks of SOF with DCV) and a post-treatment period (participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to evaluate efficacy and to monitor HCV RNA and the emergence and persistence of viral variants).

Connect with a study center

  • Site Reference ID/Investigator# 140296

    Adelaide, 5000
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140290

    Brisbane, 4102
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140299

    Camperdown, 2050
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140293

    Clayton, 3168
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140284

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140283

    Fitzroy, VIC 3065
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140283

    Fitzroy, Melbourne, 3065
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140300

    Greenslopes, 4120
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140301

    Kingswood, 2747
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140294

    Melbourne, 3004
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140295

    Parkville, 3050
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140286

    Westmead, 2145
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140290

    Woolloongabba, 4102
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 140311

    Montreal, H4A 3J1
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 140308

    Toronto, M6H 3M1
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 140355

    Vancouver, V5Z 1H2
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 140328

    Winnipeg, A3E 3P4
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 140392

    Clichy, 92110
    France

    Site Not Available

  • Site Reference ID/Investigator# 140148

    Nice, 06202
    France

    Site Not Available

  • Site Reference ID/Investigator# 147073

    Paris, 75020
    France

    Site Not Available

  • Site Reference ID/Investigator# 140414

    Paris Cedex 13, 75013
    France

    Site Not Available

  • Site Reference ID/Investigator# 140412

    Paris Cedex 14, 75679
    France

    Site Not Available

  • Site Reference ID/Investigator# 147073

    Paris, Cedex 20, 75970
    France

    Site Not Available

  • Site Reference ID/Investigator# 140404

    Rennes, 35033
    France

    Site Not Available

  • Site Reference ID/Investigator# 150736

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Site Reference ID/Investigator# 145900

    Berlin, 13353
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 145901

    Duesseldorf, 40237
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 145902

    Hamburg, 20099
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 140157

    Christchurch, Canterbury, 8011
    New Zealand

    Site Not Available

  • Site Reference ID/Investigator# 140155

    Dunedin, 9016
    New Zealand

    Site Not Available

  • Site Reference ID/Investigator# 140153

    Grafton, Auckland, 1010
    New Zealand

    Site Not Available

  • Site Reference ID/Investigator# 140158

    Hamilton, 3230
    New Zealand

    Site Not Available

  • Site Reference ID/Investigator# 140156

    Newtown, Wellington, 6021
    New Zealand

    Site Not Available

  • Site Reference ID/Investigator# 140170

    Moscow, 115446
    Russian Federation

    Site Not Available

  • Site Reference ID/Investigator# 140176

    Stavropol, 355017
    Russian Federation

    Site Not Available

  • Site Reference ID/Investigator# 143895

    Goteborg, 416 86
    Sweden

    Site Not Available

  • Site Reference ID/Investigator# 143895

    Gothenburg, 416 85
    Sweden

    Site Not Available

  • Site Reference ID/Investigator# 143893

    Linkoping, SE-581 85
    Sweden

    Site Not Available

  • Site Reference ID/Investigator# 143892

    Malmo, SE-205 02
    Sweden

    Site Not Available

  • Site Reference ID/Investigator# 143894

    Stockholm, SE 141 86
    Sweden

    Site Not Available

  • Site Reference ID/Investigator# 144206

    Basel, CH-4031
    Switzerland

    Site Not Available

  • Site Reference ID/Investigator# 143896

    Bern, 3010
    Switzerland

    Site Not Available

  • Site Reference ID/Investigator# 143898

    Lugano, 6900
    Switzerland

    Site Not Available

  • Site Reference ID/Investigator# 143899

    St. Gallen, CH-9007
    Switzerland

    Site Not Available

  • Site Reference ID/Investigator# 144207

    Zurich, 8091
    Switzerland

    Site Not Available

  • Site Reference ID/Investigator# 140211

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 150905

    Glasgow, G4 0SF
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 140213

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 140228

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 140210

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 140145

    Birmingham, Alabama 35215
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140167

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140001

    Bakersfield, California 93301
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140066

    Los Angeles, California 90036
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140107

    San Diego, California 94115
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140107

    San Francisco, California 94115
    United States

    Site Not Available

  • Site Reference ID/Investigator# 149154

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140029

    Lakewood, Colorado 80215
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140051

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140233

    Orlando, Florida 32806
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140010

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140243

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140196

    St. Paul, Minnesota 55114
    United States

    Site Not Available

  • Site Reference ID/Investigator# 149153

    Santa Fe, New Mexico 87505
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140137

    Bronx, New York 10467
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140182

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140083

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140081

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140062

    Statesville, North Carolina 28677
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140022

    Portland, Oregon 97210
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140159

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140086

    Nashville, Tennessee 37211
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140240

    Houston, Texas 77030
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140042

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Site Reference ID/Investigator# 140136

    Seattle, Washington 98922
    United States

    Site Not Available

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