Skip to main content
OpenTrials
Completed

NCT Number: NCT02243293

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection

The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C Virus Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

The study consisted of four independent parts with treatment and post-treatment periods of enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1 and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
  • Chronic HCV infection.
  • Participant had to be either HCV treatment-naïve or treatment-experienced.
  • Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).

Exclusion criteria

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

Treatment and study plan

ABT-493

Drug

Tablet

Other names: glecaprevir

ABT-530

Drug

Tablet

Other names: pibrentasvir

ribavirin (RBV)

Drug

Tablet

ABT-493/ABT-530

Drug

Tablet; ABT-493 co-formulated ABT-530

Other names: ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

    Time frame: 12 weeks after the last actual dose of study drug

    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.

  2. Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control

    Time frame: 12 weeks after the last actual dose of study drug

    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)

    Time frame: 4 weeks after the last actual dose of study drug

    SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.

  2. Percentage of Participants With On-treatment Virologic Failure

    Time frame: Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment

    On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

  3. Percentage of Participants With Post-treatment Relapse

    Time frame: From the end of treatment through 12 weeks after the last dose of study drug

    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 17, 2014
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.