- ICH GCP
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- Ensaio Clínico NCT01054729
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94115
- Quest Clinical Research
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida
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Orlando, Florida, Estados Unidos, 32803
- Orlando Immunology Center
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University
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Texas
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San Antonio, Texas, Estados Unidos, 78215
- Alamo Medical Research Center
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Virginia Mason Medical Center
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Santurce, Porto Rico, 00909
- Fundacion De Investigacion de Diego
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Treatment-naive males and females, 18-65 years of age
- Genotype 1 HCV infection
- Negative pregnancy test for females of childbearing age
- Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin
Exclusion Criteria:
- Hepatitis B or HIV infection
- Pregnant or breast feeding females or male partners of pregnant females
- Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
- History or evidence of medical condition associated with chronic liver disease other than HCV
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Sofosbuvir 100 mg+PEG+RBV
Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
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O interferon alfa-2a peguilado (PEG) 180 μg foi administrado uma vez por semana por injeção subcutânea.
Outros nomes:
Sofosbuvir tablet(s) administered orally once daily
Outros nomes:
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Outros nomes:
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Experimental: Sofosbuvir 200 mg+PEG+RBV
Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
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O interferon alfa-2a peguilado (PEG) 180 μg foi administrado uma vez por semana por injeção subcutânea.
Outros nomes:
Sofosbuvir tablet(s) administered orally once daily
Outros nomes:
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Outros nomes:
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Experimental: Sofosbuvir 400 mg+PEG+RBV
Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
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O interferon alfa-2a peguilado (PEG) 180 μg foi administrado uma vez por semana por injeção subcutânea.
Outros nomes:
Sofosbuvir tablet(s) administered orally once daily
Outros nomes:
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Outros nomes:
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Comparador Ativo: Placebo+PEG+RBV
Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
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O interferon alfa-2a peguilado (PEG) 180 μg foi administrado uma vez por semana por injeção subcutânea.
Outros nomes:
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Outros nomes:
Placebo to match sofosbuvir administered orally once daily
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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 Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Prazo: Baseline to Week 4
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Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population.
A participant was counted once if they had a qualifying event.
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Baseline to Week 4
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Circulating HCV RNA at Week 4
Prazo: Baseline to Week 4
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Baseline to Week 4
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Percentage of Participants With Rapid Virologic Response at Week 4
Prazo: Week 4
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Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.
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Week 4
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Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment
Prazo: Post-treatment Weeks 12 and 24
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SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).
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Post-treatment Weeks 12 and 24
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Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir. Cmax is defined as the maximum concentration of drug. |
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir). AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time. |
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir). AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval. |
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of GS-331007: Cmax at Day 0
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir.
GS-331007 is the predominant circulating metabolite of sofosbuvir.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of GS-331007: Cmax at Day 27
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of GS-566500: Cmax at Day 0
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir.
GS-566500 is one of the major metabolites of sofosbuvir.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of GS-566500: Cmax at Day 27
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
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Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27
Prazo: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
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Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
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Percentage of Participants Who Developed Resistance to Sofosbuvir
Prazo: Baseline to Week 4
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Baseline to Week 4
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
Outros números de identificação do estudo
- P7977-0221
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