A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
21 de março de 2016 atualizado por: Hoffmann-La Roche
Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS Doses of 180 ug or 270 ug in Combination With Copegus Doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Body Weight Greater Than 85 kg
The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon.
The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
188
Estágio
- Fase 4
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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California
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La Jolla, California, Estados Unidos, 92037-1030
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Long Beach, California, Estados Unidos, 90822
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San Diego, California, Estados Unidos, 92154
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San Diego, California, Estados Unidos, 92105
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030
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Florida
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Bradenton, Florida, Estados Unidos, 34209
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Gainesville, Florida, Estados Unidos, 32610-0214
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Jacksonville, Florida, Estados Unidos, 32207
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Wellington, Florida, Estados Unidos, 33414
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96817
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
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Missouri
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St Louis, Missouri, Estados Unidos, 63104
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New York
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Manhasset, New York, Estados Unidos, 11030
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7584
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Statesville, North Carolina, Estados Unidos, 28677
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267-0595
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
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Texas
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Houston, Texas, Estados Unidos, 77030
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Utah
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Salt Lake City, Utah, Estados Unidos, 84121
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22906-0013
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Richmond, Virginia, Estados Unidos, 23249
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Santurce, Porto Rico, 00909
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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
Descrição
Inclusion Criteria:
- adult patients >=18 years of age;
- body weight >85kg (187lbs);
- CHC (genotype 1);
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraception during study and 6 months after the study in both men and women.
Exclusion Criteria:
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection;
- previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
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
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
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600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks
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Experimental: PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
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600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks
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Experimental: PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
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600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks
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Experimental: PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
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600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks
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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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HCV RNA Profile During The First 24 Weeks
Prazo: Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
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Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed.
Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses.
Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL).
A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).
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Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
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Percentage of Participants With Virological Response Over Time to Week 24
Prazo: 72 hours post-dose, Weeks 1, 2, 4, 12, and 24
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Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.
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72 hours post-dose, Weeks 1, 2, 4, 12, and 24
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Percentage of Participants With Predicted Sustained Virological Response
Prazo: Week 4 and 12
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The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12.
Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5.
The percentage was calculated from the number of participant (N) analyzed under "Distribution of the predicted probability of an SVR."
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Week 4 and 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants With Sustained Virological Response
Prazo: Week 72
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SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.
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Week 72
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Percentage of Participants With Virological Response at the End of the Treatment Period
Prazo: Week 48
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Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.
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Week 48
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Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period
Prazo: Week 60
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Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.
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Week 60
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Percentage of Participants With Adverse Events and Serious Adverse Events
Prazo: Up to Week 72
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An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
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Up to Week 72
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Percentage of Participants With Marked Laboratory Abnormalities
Prazo: Up to Week 60
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Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 - 20.0 (g/dL),platelets 100 - 700 (10^9/L), lymphocyte 1.00 - 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 - 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 - 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 - 50 (U/L), alkaline phosphatase 0 - 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 - 120 (U/L),Total protein 55 - 87 (g/L),total bilirubin 0 - 34.2 (μmol/L),BUN 0 - 14.3 (mmol/L),creatinine 0 - 154 (μmol/L),chloride 95 - 115 (mmol/L),potassium 3.0 - 6.0 (mmol/L), sodium 130 - 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 - 10.0 (mU/L),triglycerides 0.00 - 2.83 (mmol/L), calcium 2.00 - 2.90 (mmol/L),phosphate 0.75 - 1.60 (mmol/L),Blood Glucose 2.80 - 11.10 (mmol/L),Uric Acid 0 - 600 (μmol/L),proteinuria 0 - 1 (0 to 4+), glycosuria 0 - 1 (0 to 4+), hematuria 0 - 1 (0 to 4+).
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Up to Week 60
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Percentage of Participants With Abnormal Vital Signs
Prazo: Up to Week 72
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Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening.
High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline.
High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline.
Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline.
High heart rate is defined as >120 beats/minute and >20% increase from baseline.
Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline.
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Up to Week 72
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Total BDI-II (Beck Depression Inventory) Scores
Prazo: From Baseline (Day 1) to Week 72
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The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group.
All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63.
The scores for each item were summed to obtain the total for that assessment.
The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63.
The BDI-II questionnaire was self-administered by the patient at each visit.
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From Baseline (Day 1) to Week 72
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 janeiro de 2004
Conclusão Primária (Real)
1 de dezembro de 2005
Conclusão do estudo (Real)
1 de dezembro de 2005
Datas de inscrição no estudo
Enviado pela primeira vez
10 de fevereiro de 2004
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de fevereiro de 2004
Primeira postagem (Estimativa)
13 de fevereiro de 2004
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de abril de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de março de 2016
Última verificação
1 de março de 2016
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 Crônica
- Hepatite
- Hepatite A
- Hepatite C
- Hepatite C Crônica
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Antimetabólitos
- Agentes Antineoplásicos
- Fatores imunológicos
- Interferon-alfa
- Ribavirina
- Peginterferon alfa-2a
- Interferon alfa-2
- Interferon-alfa-1b
Outros números de identificação do estudo
- NV17318
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 .