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- Ensaio Clínico NCT02851069
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia (outCome)
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Colombia (outCome)
This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label.
This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.
Visão geral do estudo
Status
Condições
Descrição detalhada
This prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN with or without RBV are offered the opportunity to participate in this study during a routine clinical visit at the participating sites at the discretion of the physician and is made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study.
After written informed consent is obtained, demographics, HCV disease characteristics, co-morbidities, co-medication, treatment details, and laboratory assessments as recorded in the participant's medical records (source documentation) are documented in the electronic case report form (eCRF). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion. No patient identifiable information was captured; a unique participant number was automatically allocated by the web based system once the investigator or designee created a new participant file.
This study focuses on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods follow physicians' routine clinical practice. The observational study period entailed the following data collection schemes:
- 12-week treatment regimen: four visits plus two interim data collection windows
- 24-week treatment regimen: four visits plus three interim data collection windows This schedule was based on the anticipated regular follow-up for patients undergoing treatment for CHC.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Bogotá, Colômbia
- Fundación Cardioinfantil
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Cali, Colômbia, 760001
- Cic Cali
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Cali, Colômbia
- Centro Medico lmbanaco de Cali I
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Cartagena, Colômbia, 130013
- Pharos Centro de Estudios Clin
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Manizales, Colômbia, 170004
- IPS Medicos Internistas Del Ca I
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Medellín, Colômbia, 050010
- Fundacion Hospitalaria San Vin
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± ribavirin (RBV) according to standard of care and in line with the current local label.
- If RBV is co-administered with the ABBVIE REGIMEN , it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
- Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.
Exclusion Criteria:
- None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Participants with Hepatitis C Virus Genotype 1 (HCV + GT1)
ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] with or without dasabuvir [250 mg twice daily]), and with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks in HCV + GT1 participants.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment
Prazo: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
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SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]).
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12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants With Virologic Response at End of Treatment (EoT)
Prazo: Up to EoT, maximum of 24 weeks
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Virologic response is defined as HCV RNA level <50 IU/mL.
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Up to EoT, maximum of 24 weeks
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Number of Participants Meeting Premature Study Drug Discontinuation
Prazo: Up to EoT, maximum of 24 weeks
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Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]).
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Up to EoT, maximum of 24 weeks
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Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria
Prazo: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)
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For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:
Abbreviations: EoT=end of treatment. |
During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)
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Percentage of Participants With Relapse
Prazo: 12 weeks (i.e. at least 70 days) after the last dose of study drug
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Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated.
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12 weeks (i.e. at least 70 days) after the last dose of study drug
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Percentage of Participants With Relapse at EoT
Prazo: 12 weeks (i.e. at least 70 days) after the last dose of study drug
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Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.
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12 weeks (i.e. at least 70 days) after the last dose of study drug
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Percentage of Participants With Viral Breakthrough
Prazo: Up to EoT, maximum of 24 weeks
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Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
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Up to EoT, maximum of 24 weeks
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Percentage of Participants Meeting On-treatment Virologic Failure
Prazo: Up to EoT, maximum of 24 weeks
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On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL).
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Up to EoT, maximum of 24 weeks
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Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)
Prazo: Week 4
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RVR4 was defined as HCV RNA < 50 IU/mL at Week 4.
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Week 4
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Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT
Prazo: 24 weeks after EoT (up to 24 weeks)
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SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT.
During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.
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24 weeks after EoT (up to 24 weeks)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT
Prazo: EoT (up to 24 weeks)
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The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants.
The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS.
The higher the score, the worse the quality of life.
For the VAS, the higher the score, the better the quality of life.
Participant responses to the EQ-5D-5L were used to generate a health status index (HSI).
HSI ranges is anchored at 0 (dead) and 1 (full health).
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EoT (up to 24 weeks)
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EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT
Prazo: 12 weeks post EoT (up to 24 weeks)
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The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants.
The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS.
The higher the score, the worse the quality of life.
For the VAS, the higher the score, the better the quality of life.
Participant responses to the EQ-5D-5L were used to generate a HSI.
HSI ranges is anchored at 0 (dead) and 1 (full health).
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12 weeks post EoT (up to 24 weeks)
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EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT
Prazo: 24 weeks post EoT (up to 24 weeks)
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The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants.
The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS.
The higher the score, the worse the quality of life.
For the VAS, the higher the score, the better the quality of life.
Participant responses to the EQ-5D-5L were used to generate a HSI.
HSI ranges is anchored at 0 (dead) and 1 (full health).
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24 weeks post EoT (up to 24 weeks)
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EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT
Prazo: End of Treatment (up to 24 weeks)
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The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants.
Participants also rated their perception of their overall health on a separate VAS.
The scale is numbered from 0 to 100.
The higher the score, the better the quality of life.
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End of Treatment (up to 24 weeks)
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EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT
Prazo: 12 weeks post EoT (up to 24 weeks)
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The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants.
Participants also rated their perception of their overall health on a separate VAS.
The scale is numbered from 0 to 100.
The higher the score, the better the quality of life.
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12 weeks post EoT (up to 24 weeks)
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EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT
Prazo: 24 weeks post EoT (up to 24 weeks)
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The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants.
Participants also rated their perception of their overall health on a separate VAS.
The scale is numbered from 0 to 100.
The higher the score, the better the quality of life.
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24 weeks post EoT (up to 24 weeks)
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Number of Participants With Co-morbidities at Baseline (Day 0)
Prazo: Baseline (Day 0)
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Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus [HIV] or hepatitis B virus [HBV], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other).
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Baseline (Day 0)
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Number of Participants With Concomitant Medications
Prazo: Day 0 to EoT, maximum 24 weeks
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This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose. Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux. |
Day 0 to EoT, maximum 24 weeks
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças do Fígado
- Infecções por Flaviviridae
- Hepatite, Viral, Humana
- Infecções por Enterovírus
- Infecções por Picornaviridae
- Hepatite
- Hepatite A
- Hepatite C
- Hepatite Crônica
- Hepatite C Crônica
Outros números de identificação do estudo
- P16-024
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
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