Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C (INTEGRATE)
1 de março de 2017 atualizado por: Janssen Pharmaceutica N.V., Belgium
Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts
The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This is a multicenter, non-interventional, observational, prospective study to evaluate the efficacy, safety, and adherence to telaprevir in ex-People Who Inject Drugs (ex-PWIDs) infected with genotype 1 chronic hepatitis C and any fibrosis stage including compensated cirrhosis, who are receiving substitution therapy (eg, methadone, buprenorphine) and/or are being followed in an addiction center.
Patients may be treatment naïve or relapsers.
Participating physicians are to offer enrollment in this study to all eligible patients at their site in who they plan to initiate triple therapy with telaprevir, pegylated interferon alfa (PegIFN alfa), and ribavirin (RBV).
A target of 115 patients will participate in this study.
The duration of each patient's participation in this study will be up to approximately 60 weeks.
After obtaining the signed participation agreement or ICF, selection criteria will be reviewed to verify the patient's eligibility.
Data will be recorded in the electronic case report form (CRF) at 6 time points for each patient which correspond to routine care visits: inclusion, and at the patient's routine care visit closest to Week 4, 12, and 24, end of treatment, and end-of-follow-up (e.g., approximately 12 weeks after end-of-treatment).
No additional blood, urine, or other biological samples will be required, and no additional investigations, beyond the routine clinical management of the patient, will be performed.
Tipo de estudo
Observacional
Inscrição (Real)
50
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha
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Biberach, Alemanha
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Kassel, Alemanha
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München, Alemanha
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Münster, Alemanha
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Antwerpen, Bélgica
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Brussels, Bélgica
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Bruxelles, Bélgica
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Genk, Bélgica
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Haine-Saint-Paul, Bélgica
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Lomme, França
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Montpellier, França
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Perpignan Cedex, França
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Maastricht, Holanda
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Dundee, Reino Unido
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London, Reino Unido
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Nottingham, Reino Unido
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Lausanne, Suíça
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Zürich, Suíça
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Men or women who have HCV infection genotype 1, a quantifiable serum HCV RNA, documentation of the degree of liver fibrosis assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan), physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV, have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers), have a history of injecting drugs, and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center will be eligible to enter this study.
Descrição
Inclusion Criteria:
Have HCV genotype 1, a quantifiable serum HCV RNA, recent (within 18 months of baseline) documentation of the degree of liver fibrosis (Metavir F0-F4; Ishak 0-6) assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan); Physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV; Have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers); History of injecting drugs and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center.
Exclusion Criteria:
Infected or coinfected with HCV of a genotype other than genotype 1; Previous or current treatment with a DAA therapy; Have any contraindication specified in the SmPC for telaprevir, PegIFN alfa, or RBV; Have a history or other evidence of decompensated liver disease, or have coinfection with active hepatitis B or HIV; Currently participating in another investigational study or clinical study.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Sustained Virologic Response at 12 weeks (SVR12)
Prazo: Week 12
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HCV RNA <25 IU/mL, at 12 weeks (SVR12) after the last dose of anti-HCV treatment (telaprevir, PegIFN alfa, RBV)
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Week 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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adherence to telaprevir until Week 12
Prazo: week 12
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adherence as measured by pill count and/or patient questionnaire (modified medication adherence self-report inventory [M-MASRI]
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week 12
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adherence to PegIFN alfa and RBV
Prazo: at end of treatment (week 24)
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adherence as measured by pill/vial count and/or patient questionnaire (M-MASRI)
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at end of treatment (week 24)
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on-treatment virologic response undetectable
Prazo: week 12 and end of treatment ()
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rapid virologic response [RVR] and extended rapid virologic response [eRVR], Week 12, end of treatment) based on viral load, as measured by HCV RNA <25 IU/mL undetectable
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week 12 and end of treatment ()
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on treatment virologic response
Prazo: week 12 and end of treatment ()
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rapid virologic response [RVR] and extended rapid virologic response [eRVR], Week 12, end of treatment) based on viral load, as measured by HCV RNA <25 IU/mL
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week 12 and end of treatment ()
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health-related quality of life based on EQ-5D
Prazo: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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The EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses.
The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems).
A standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state is also included ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
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on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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Hospital Anxiety and Depression Scale (HADS)
Prazo: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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HADS is a validated 14-item scale with 7 of the items relating to anxiety and 7 relating to depression.
Each item is scored from 0 to 3, with higher scores indicating greater likelihood of depression or anxiety.
Cases of anxiety or depression are each defined by subscale scores of 8 or greater, and categorized as normal (score of 0-7), mild (score of 8-10), moderate (score of 11-14), and severe (score of 15-21).
The recall period is the past week.
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on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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alcohol use disorders identification test (AUDIT)
Prazo: on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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The AUDIT questionnaire consists of 10 questions about a patient's quantity and frequency of alcohol use.
The response to 8 of the questions are scored as 0 = never, 1 = monthly or less, 2 = 2 to 4 times a month, 3 = 2 to 3 times a week, 4 = 4 or more times a week.
Two questions are scored as 0 = no, 2 = yes, but not in the last year, 4 = yes, during the last year.
A score of 8 or more is associated with harmful or hazardous drinking
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on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2013
Conclusão Primária (Real)
1 de fevereiro de 2015
Conclusão do estudo (Real)
1 de fevereiro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
4 de novembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de novembro de 2013
Primeira postagem (Estimativa)
8 de novembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de março de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de março de 2017
Última verificação
1 de março de 2017
Mais Informações
Termos relacionados a este estudo
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
- CR100966
- VX-950HPC4017 (Outro identificador: Janssen Pharmaceutica NV - CTMS ID)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .