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Hepatitis C Virus (HCV)Phase 3NCT03219216

A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection

A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 14 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus (HCV)
What is being tested?
Glecaprevir/Pibrentasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
14 sitesBrazil
Study dates
6 Jun 2018to 11 Mar 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Brazil14 sites

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

    Botucatu, São Paulo, 18618-686

  • Instituto de Infectologia Campinas /ID# 163175

    Campinas, São Paulo, 13015-080

  • Universidade Estadual de Maringá /ID# 166436

    Maringá, Paraná, 87083-068

  • Hospital de Clinicas de Porto Alegre /ID# 163166

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital de Clinicas de Porto Alegre /ID# 163167

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Ernesto Dornelles /ID# 163171

    Porto Alegre, Rio Grande do Sul, 90160-093

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

    Ribeirão Preto, São Paulo, 14048-900

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

    São Luís, Maranhão, 65045-040

  • Instituto de Infectologia Emilio Ribas /ID# 163170

    São Paulo, São Paulo, 01246-900

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

    São Paulo, São Paulo, 05403-000

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

    São Paulo, 04037-003

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

    São Paulo, 04121-000

  • Hospital Heliopolis /ID# 163063

    São Paulo, 04231-030

  • Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512

    Vitória, Espírito Santo, 29 043-260

Other trials in Brazil

About this study

Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naïve Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection

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.

Read the detailed description

This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of GLE/PIB for an 8- or 12-week treatment duration in adults in Brazil with chronic HCV GT1 to GT6 infection, without cirrhosis or with compensated cirrhosis with a METAVIR System Fibrosis Score of F2 to F3 (without cirrhosis) or F4 (with compensated cirrhosis) or equivalent, who were HCV treatment-naïve.

Being tested
Glecaprevir/Pibrentasvir
Keywords
Chronic Hepatitis C Virus (HCV), Genotype 1 - 6, Metavir System Fibrosis Score, Glecaprevir, Pibrentasvir, Treatment naïve, Cirrhosis, Compensated cirrhosis
Medical subject headings
Hepatitis C, Hepatitis C, Chronic, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glecaprevir/PibrentasvirDrug

    Also called ABT-493, ABT-530, MAVYRET

    Film-coated tablet

Study groups in NCT03219216
Study groupRoleWhat they receive
Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeksExperimentalArm 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.
Receives: Drug: Glecaprevir/Pibrentasvir
Arm B: GLE/PIB for 12 WeeksExperimentalArm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.
Receives: Drug: Glecaprevir/Pibrentasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Percentage of Participants With On-treatment HCV Virologic Failure

    On-treatment HCV virologic failure was defined as one of the following:

    • Confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ 100 IU/mL after HCV RNA < 15 IU/mL at any time point during treatment; or
    • Confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during study drug treatment; or
    • HCV RNA ≥ 15 IU/mL at the end of treatment with at least 6 weeks of treatment.

    Measured: 8 or 12 weeks (depending on treatment regimen)

  2. Percentage of Participants With Post-treatment HCV Virologic Relapse

    Post-treatment HCV virologic relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA levels < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2017
  2. Study start6 Jun 2018
  3. Primary completion11 Mar 2019
  4. Study completion11 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03219216
Sponsor's protocol ID
M16-156
Status last verified
Mar 2020
First submitted
13 Jul 2017
Last updated
17 Mar 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35174470

  • 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.

    PubMed 32949786

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 14 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03219216, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

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