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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir/Pibrentasvir | Drug | Film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With On-treatment HCV Virologic Failure | On-treatment HCV virologic failure was defined as one of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512 | Vitória | EspÃrito Santo | 29 043-260 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35174470 | Derived | 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. | |
| 32949786 | Derived |
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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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
A total of 100 participants were enrolled and received ≥ 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks | 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. |
| FG001 | Arm B: GLE/PIB for 12 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2018 | Feb 5, 2020 |
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| 8 or 12 weeks (depending on treatment regimen) |
| 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. | From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug |
| Hospital Universitario da Universidade Federal do Maranhao - CEPEC /ID# 163169 |
| São LuÃs |
| Maranhão |
| 65045-040 |
| Brazil |
| Universidade Estadual de Maringá /ID# 166436 | Maringá | Paraná | 87083-068 | Brazil |
| Hospital de Clinicas de Porto Alegre /ID# 163166 | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital de Clinicas de Porto Alegre /ID# 163167 | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Ernesto Dornelles /ID# 163171 | Porto Alegre | Rio Grande do Sul | 90160-093 | Brazil |
| Unidade de Pesquisa ClÃnica da Faculdade de Medicina de Botucatu /ID# 163066 | Botucatu | São Paulo | 18618-686 | Brazil |
| Instituto de Infectologia Campinas /ID# 163175 | Campinas | São Paulo | 13015-080 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163054 | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Instituto de Infectologia Emilio Ribas /ID# 163170 | São Paulo | São Paulo | 01246-900 | Brazil |
| Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 163168 | São Paulo | São Paulo | 05403-000 | Brazil |
| UNIFESP/Unidade de Atendimento Pesquisa ClÃnica 1 /ID# 164188 | São Paulo | 04037-003 | Brazil |
| Centro de Referência e Treinamento DST/AIDS /ID# 163174 | São Paulo | 04121-000 | Brazil |
| Hospital Heliopolis /ID# 163063 | São Paulo | 04231-030 | Brazil |
| 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. |
Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks | 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. |
| BG001 | Arm B: GLE/PIB for 12 Weeks | Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg once daily (QD) for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All enrolled participants who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders. Data are reported for the overall study population according to the prespecified analysis plan for this study. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen) |
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| Secondary | Percentage of Participants With On-treatment HCV Virologic Failure | On-treatment HCV virologic failure was defined as one of the following:
| All enrolled participants who received at least 1 dose of study drug. Data are reported for the overall study population according to the prespecified analysis plan for this study. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 or 12 weeks (depending on treatment regimen) |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | All enrolled participants who received at least 1 dose of study drug and who completed treatment, had HCV RNA < 15 IU/mL at final treatment visit, and had at least one post-treatment HCV RNA value. Data are reported for the overall study population according to the prespecified analysis plan for this study. | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug |
|
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All enrolled participants who received at least one dose of study drug. | 0 | 100 | 4 | 100 | 30 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2019 | Feb 5, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
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| Male |
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| Black or African American |
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| Asian |
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| Multi-race |
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