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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03219216|
Recruitment Status : Completed
First Posted : July 17, 2017
Results First Posted : March 17, 2020
Last Update Posted : March 17, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus (HCV)||Drug: Glecaprevir/Pibrentasvir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 6, 2018|
|Actual Primary Completion Date :||March 11, 2019|
|Actual Study Completion Date :||March 11, 2019|
Experimental: 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.
Experimental: 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 QD for 12 weeks.
- 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) ]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.
- Percentage of Participants With On-treatment HCV Virologic Failure [ Time Frame: 8 or 12 weeks (depending on treatment regimen) ]
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.
- Percentage of Participants With Post-treatment HCV Virologic Relapse [ Time Frame: From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219216
|Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512|
|Vitoria, Espirito Santo, Brazil, 29 043-260|
|Hospital Universitario da Universidade Federal do Maranhao - CEPEC /ID# 163169|
|São Luís, Maranhao, Brazil, 65045-040|
|Universidade Estadual de Maringá /ID# 166436|
|Maringá, Parana, Brazil, 87083-068|
|Hospital de Clinicas de Porto Alegre /ID# 163166|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|
|Hospital de Clinicas de Porto Alegre /ID# 163167|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|
|Hospital Ernesto Dornelles /ID# 163171|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093|
|Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 163066|
|Botucatu, Sao Paulo, Brazil, 18618-686|
|Instituto de Infectologia Campinas /ID# 163175|
|Campinas, Sao Paulo, Brazil, 13015-080|
|Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163054|
|Ribeirão Preto, Sao Paulo, Brazil, 14048-900|
|Instituto de Infectologia Emilio Ribas /ID# 163170|
|São Paulo, Sao Paulo, Brazil, 01246-900|
|Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 163168|
|São Paulo, Sao Paulo, Brazil, 05403-000|
|UNIFESP/Unidade de Atendimento Pesquisa Clínica 1 /ID# 164188|
|Sao Paulo, Brazil, 04037-003|
|Centro de Referência e Treinamento DST/AIDS /ID# 163174|
|Sao Paulo, Brazil, 04121-000|
|Hospital Heliopolis /ID# 163063|
|Sao Paulo, Brazil, 04231-030|
|Study Director:||AbbVie Inc.||AbbVie|
Documents provided by AbbVie:
|Other Study ID Numbers:||
|First Posted:||July 17, 2017 Key Record Dates|
|Results First Posted:||March 17, 2020|
|Last Update Posted:||March 17, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Chronic Hepatitis C Virus (HCV)
Genotype 1 - 6
Metavir System Fibrosis Score
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections