The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

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

Phase

3

Condition

Liver Disorders

Hepatitis

Hiv

Treatment

N/A

Clinical Study ID

NCT02636595
M13-583
2015-002349-80
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
  2. Chronic HCV infection.
  3. HCV treatment-naïve or treatment experienced (interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV]; sofosbuvir [SOF] plus RBV with or withoutpegIFN).
  4. Non-cirrhotic participants.

Exclusion

Exclusion Criteria:

  1. History of severe, life-threatening or other significant sensitivity to any excipientof the study drugs.
  2. Female who is pregnant, planning to become pregnant during the study, orbreastfeeding; or male whose partner is pregnant or planning to become pregnant duringthe study.
  3. Recent (within 6 months prior to study drug administration) history of drug or alcoholabuse that could preclude adherence to the protocol in the opinion of theinvestigator.
  4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) oranti-human immunodeficiency virus antibody (HIV Ab).
  5. Co-infection with more than one HCV genotype.

Study Design

Total Participants: 121
Study Start date:
November 01, 2015
Estimated Completion Date:
January 31, 2017

Connect with a study center

  • Site Reference ID/Investigator# 142495

    Brussels, 1200
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 142495

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 142498

    Leuven, 3000
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 144210

    Montreal, H4A 3J1
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 144208

    Ottawa, K1H 8L6
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 144209

    Toronto, M6H 3M1
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 142519

    Bondy Cedex, 93140
    France

    Site Not Available

  • Site Reference ID/Investigator# 142507

    Clichy, 92110
    France

    Site Not Available

  • Site Reference ID/Investigator# 142443

    Creteil, 94010
    France

    Site Not Available

  • Site Reference ID/Investigator# 142445

    Limoges, 87042
    France

    Site Not Available

  • Site Reference ID/Investigator# 142477

    Nice Cedex 3, 06202
    France

    Site Not Available

  • Site Reference ID/Investigator# 142477

    Nice, Cedex 3, 06202
    France

    Site Not Available

  • Site Reference ID/Investigator# 142450

    Milan, 20157
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 142492

    Milano, 20122
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 142505

    Roma, 00149
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 142505

    Rome, 00149
    Italy

    Site Not Available

  • Site Reference ID/Investigator# 144841

    Lisbon, 1169-050
    Portugal

    Site Not Available

  • Site Reference ID/Investigator# 142469

    Porto, 4369-004
    Portugal

    Site Not Available

  • Site Reference ID/Investigator# 142833

    Cape Town, 7925
    South Africa

    Site Not Available

  • Site Reference ID/Investigator# 142832

    Parktown, 2193
    South Africa

    Site Not Available

  • Site Reference ID/Investigator# 142829

    Soweto, 1804
    South Africa

    Site Not Available

  • Site Reference ID/Investigator# 142738

    Madrid, 28034
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 142460

    Palma de Mallorca, 07120
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 142595

    Sevilla, 41013
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 142595

    Sevilla- (Espana), 41013
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 142461

    Valencia, 46014
    Spain

    Site Not Available

  • Site Reference ID/Investigator# 142635

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 142603

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 142627

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 142643

    Manchester, M8 5RB
    United Kingdom

    Site Not Available

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