NCT02243293

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
694

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

September 19, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 2, 2017

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

September 4, 2014

Results QC Date

August 31, 2017

Last Update Submit

July 9, 2021

Conditions

Chronic Hepatitis CHepatitis C Virus

Keywords

Hepatitis C Virus (HCV)Hepatitis CChronic Hepatitis Cinterferon freeHepatitis C Genotype 2Hepatitis C Genotype 3Hepatitis C Genotype 4Hepatitis C Genotype 5Hepatitis C Genotype 6

Outcome Measures

Primary Outcomes (2)

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

    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.

    12 weeks after the last actual dose of study drug

  • 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

    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.

    12 weeks after the last actual dose of study drug

Secondary Outcomes (3)

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

    4 weeks after the last actual dose of study drug

  • Percentage of Participants With On-treatment Virologic Failure

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

  • Percentage of Participants With Post-treatment Relapse

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

Study Arms (22)

Arm A

EXPERIMENTAL

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm B

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm C

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530Drug: ribavirin (RBV)

Arm D

EXPERIMENTAL

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm E

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm F

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530Drug: ribavirin (RBV)

Arm G

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm H

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm I

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm J

EXPERIMENTAL

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm K

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm L

EXPERIMENTAL

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm M

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm N

EXPERIMENTAL

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD and ribavirin (RBV) (800 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis.

Drug: ABT-493Drug: ABT-530Drug: ribavirin (RBV)

Arm O

EXPERIMENTAL

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis.

Drug: ABT-493Drug: ABT-530

Arm P

EXPERIMENTAL

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis.

Drug: ABT-493Drug: ABT-530Drug: ribavirin (RBV)

Arm Q1

EXPERIMENTAL

ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis.

Drug: ABT-493/ABT-530

Arm Q2

EXPERIMENTAL

ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.

Drug: ABT-493/ABT-530

Arm R1

EXPERIMENTAL

ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis.

Drug: ABT-493/ABT-530

Arm R2

EXPERIMENTAL

ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis.

Drug: ABT-493/ABT-530

Arm S1

EXPERIMENTAL

ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493/ABT-530

Arm S2

EXPERIMENTAL

ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis.

Drug: ABT-493/ABT-530

Interventions

ABT-493DRUG

Tablet

Also known as: glecaprevir
Arm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm KArm LArm MArm NArm OArm P
ABT-530DRUG

Tablet

Also known as: pibrentasvir
Arm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm KArm LArm MArm NArm OArm P
ribavirin (RBV)DRUG

Tablet

Arm CArm FArm NArm P
ABT-493/ABT-530DRUG

Tablet; ABT-493 co-formulated ABT-530

Also known as: ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET
Arm Q1Arm Q2Arm R1Arm R2Arm S1Arm S2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017 Aug;67(2):263-271. doi: 10.1016/j.jhep.2017.03.039. Epub 2017 Apr 13.

    PMID: 28412293BACKGROUND

  • Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18.

    PMID: 31568620DERIVED

  • Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.

    PMID: 30977945DERIVED

  • Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022.

    PMID: 30923816DERIVED

  • Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10.

    PMID: 30012435DERIVED

  • Asselah T, Kowdley KV, Zadeikis N, Wang S, Hassanein T, Horsmans Y, Colombo M, Calinas F, Aguilar H, de Ledinghen V, Mantry PS, Hezode C, Marinho RT, Agarwal K, Nevens F, Elkhashab M, Kort J, Liu R, Ng TI, Krishnan P, Lin CW, Mensa FJ. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. Clin Gastroenterol Hepatol. 2018 Mar;16(3):417-426. doi: 10.1016/j.cgh.2017.09.027. Epub 2017 Sep 22.

    PMID: 28951228DERIVED

  • Gane E, Poordad F, Wang S, Asatryan A, Kwo PY, Lalezari J, Wyles DL, Hassanein T, Aguilar H, Maliakkal B, Liu R, Lin CW, Ng TI, Kort J, Mensa FJ. High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis. Gastroenterology. 2016 Oct;151(4):651-659.e1. doi: 10.1053/j.gastro.2016.07.020. Epub 2016 Jul 25.

    PMID: 27456384DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

glecaprevirpibrentasvirRibaviringlecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 17, 2014

Study Start

September 19, 2014

Primary Completion

October 25, 2016

Study Completion

February 23, 2017

Last Updated

July 30, 2021

Results First Posted

October 2, 2017

Record last verified: 2021-07