NCT03219216

Brief Summary

This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

14 active sites

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

July 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

June 6, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

July 13, 2017

Results QC Date

February 17, 2020

Last Update Submit

March 4, 2020

Conditions

Hepatitis C Virus (HCV)

Keywords

Chronic Hepatitis C Virus (HCV)Genotype 1 - 6Metavir System Fibrosis ScoreGlecaprevirPibrentasvirTreatment naïveCirrhosisCompensated cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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; less than 15 IU/mL) 12 weeks after the last dose of study drug.

    12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen)

Secondary Outcomes (2)

  • Percentage of Participants With On-treatment HCV Virologic Failure

    8 or 12 weeks (depending on treatment regimen)

  • Percentage of Participants With Post-treatment HCV Virologic Relapse

    From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug

Study Arms (2)

Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks

EXPERIMENTAL

Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.

Drug: Glecaprevir/Pibrentasvir

Arm B: GLE/PIB for 12 Weeks

EXPERIMENTAL

Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.

Drug: Glecaprevir/Pibrentasvir

Interventions

Glecaprevir/PibrentasvirDRUG

Film-coated tablet

Also known as: ABT-493, ABT-530, MAVYRET
Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeksArm B: GLE/PIB for 12 Weeks

Eligibility Criteria

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

You may qualify if:

  • Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit.
  • Participant must have been documented as without cirrhosis with METAVIR equivalent fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a liver biopsy, or FibroScan, or FibroTest score.
  • Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected may have been enrolled if they had a positive test result for anti-HIV antibody at Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline.
  • Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma (HCC) within 3 months prior to Screening or a negative ultrasound at Screening.

You may not qualify if:

  • Current hepatitis B virus (HBV) infection on screening tests.
  • Any current or past clinical evidence of Child-Pugh B or C classification (score of \> 6) or clinical history of liver decompensation including ascites on physical exam, including hepatic encephalopathy or variceal bleeding.
  • Receipt of any investigational or commercially available anti-HCV agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512

Vitória, Espírito Santo, 29 043-260, Brazil

Location

Hospital Universitario da Universidade Federal do Maranhao - CEPEC /ID# 163169

São Luís, Maranhão, 65045-040, Brazil

Location

Universidade Estadual de Maringá /ID# 166436

Maringá, Paraná, 87083-068, Brazil

Location

Hospital de Clinicas de Porto Alegre /ID# 163166

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital de Clinicas de Porto Alegre /ID# 163167

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Ernesto Dornelles /ID# 163171

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

Location

Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 163066

Botucatu, São Paulo, 18618-686, Brazil

Location

Instituto de Infectologia Campinas /ID# 163175

Campinas, São Paulo, 13015-080, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163054

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Instituto de Infectologia Emilio Ribas /ID# 163170

São Paulo, São Paulo, 01246-900, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 163168

São Paulo, São Paulo, 05403-000, Brazil

Location

UNIFESP/Unidade de Atendimento Pesquisa Clínica 1 /ID# 164188

São Paulo, 04037-003, Brazil

Location

Centro de Referência e Treinamento DST/AIDS /ID# 163174

São Paulo, 04121-000, Brazil

Location

Hospital Heliopolis /ID# 163063

São Paulo, 04231-030, Brazil

Location

Related Publications (2)

  • Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.

    PMID: 35174470DERIVED

  • Peribanez-Gonzalez M, Cheinquer H, Rodrigues L, Lima MP, Alvares-da-Silva MR, Madruga J, Parise ER, Pessoa MG, Furtado J, Villanova M, Ferreira A, Mazzoleni F, Nascimento E, Silva GF, Fredrick L, Krishnan P, Burroughs M, Reuter T. Efficacy and safety of glecaprevir/pibrentasvir in treatment-naive adults with chronic hepatitis C virus genotypes 1-6 in Brazil. Ann Hepatol. 2021 Jan-Feb;20:100257. doi: 10.1016/j.aohep.2020.09.002. Epub 2020 Sep 17.

    PMID: 32949786DERIVED

MeSH Terms

Conditions

Hepatitis CHepatitis C, ChronicFibrosis

Interventions

glecaprevir and pibrentasvirglecaprevirpibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 17, 2017

Study Start

June 6, 2018

Primary Completion

March 11, 2019

Study Completion

March 11, 2019

Last Updated

March 17, 2020

Results First Posted

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
More information

Locations

BR(14)