- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00277238
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
CPG 10101 Combination Therapy for the Treatment of Hepatitis C: A Phase II Randomized, Open Label, Multi-Center, Parallel Arm, Controlled Trial of CPG 10101 at Two Different Dose Levels With Pegylated-Interferon-Alpha 2B (PEG-IFN) Plus Ribavirin (RBV) or PEG-IFN Plus RBV Without CPG 10101 in the Treatment of Non-Responder (Null and Partial Responder) HCV Genotype 1 Infected Subjects
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Pfizer Investigational Site
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Pfizer Investigational Site
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70115
- Pfizer Investigational Site
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Michigan
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Detroit, Michigan, Estados Unidos, 48202-2689
- Pfizer Investigational Site
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Missouri
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Kansas City, Missouri, Estados Unidos, 64131
- Pfizer Investigational Site
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St. Louis, Missouri, Estados Unidos, 63104
- Pfizer Investigational Site
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New York
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New York, New York, Estados Unidos, 10021
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Pfizer Investigational Site
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Pfizer Investigational Site
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Pfizer Investigational Site
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Tennessee
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Germantown, Tennessee, Estados Unidos, 38138
- Pfizer Investigational Site
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Texas
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Dallas, Texas, Estados Unidos, 75208
- Pfizer Investigational Site
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San Antonio, Texas, Estados Unidos, 78215
- Pfizer Investigational Site
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Virginia
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Richmond, Virginia, Estados Unidos, 23249
- Pfizer Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
HCV positive subjects documented by serum HCV RNA concentration > 100,000 IU/mL within 21 days of first study treatment Receipt of adequate previous PEG-IFN and RBV therapy for a minimum of 12 weeks (PEG-IFN alpha-2a doses of > 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at least 800 mg RBV daily) not resulting in a minimum of a 2 log decrease in HCV RNA concentrations while on treatment (null responders). Or, receipt of adequate previous treatment PEG-IFN and RBV therapy for a minimum of 24 weeks (PEG-IFN alpha-2a doses of ≥ 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at least 800 mg RBV daily) resulting in a minimum of a 2 log decrease in serum HCV RNA concentrations by 12 weeks of treatment but not resulting in an undetectable viral load after 24 weeks of treatment (partial responders). If dose modifications were necessary during the treatment due to adverse events, the subject must have received at least 80% of the PEG-IFN dose and 80% of the RBV dose to be eligible for the study.
HCV genotype 1 only; other HCV genotypes are excluded. Adults, 18+ years old Written informed consent Liver biopsy within 5 years of the first dose of study drug, documenting changes consistent with hepatitis C
Adequate bone marrow, liver, and renal function demonstrated by:
- Hemoglobin > 12 g/dL for females and > 13 g/dL for males
- White blood cell (WBC) > 3,000/mm3
- Neutrophils > 1,500/mm3
- Platelets > 80,000/mm3
- Total bilirubin < 1.6 mg/dL
- Direct bilirubin < 1.5 upper limit of normal. If indirect bilirubin is elevated, Gilbert's disease must be documented in chart and substantiated.
- Albumin > 3.7 g/dL and < 4.9 g/dL
- Serum creatinine < upper limit of normal per central laboratory. If serum creatinine is > upper limit of normal then calculated creatinine clearance has to be > 100 mL/min (by Cockcroft-Gault formula) for patient to be eligible.
Negative pregnancy test in women of childbearing potential. Females of childbearing potential and males who have partners of childbearing potential must use two forms of effective contraception during treatment and during the 6 months after treatment has been concluded.
Serum thyroid stimulating hormone (TSH) levels within normal ranges within 21 days of first study treatment, regardless of treatment with L-thyroxin.
Exclusion Criteria:
Treatment with any IFN based therapies and/or antiviral therapies within 30 days of the first dose of study drug Subjects who have previously received an HCV vaccine Child-Pugh Class B or C History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Subjects with mild to moderate depression in the past who have a normal to mild Beck Depression Inventory score and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator's opinion, they are suitable for treatment.
Significant cardiovascular disease (e.g., New York Heart Association [NYHA] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias) History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogeneic transplant, or pre-existing autoimmune or antibody-mediated disease including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
Other serious medical conditions including, but not limited to:
- HIV-1
- Hepatitis B (positive hepatitis B surface antigen [HBsAg])
- Cancer (active tumors in the last 5 years)
- Pregnant, partners of pregnant women, or nursing women
- Alcohol or drug misuse within 90 days of screening Use of immunosuppressive doses of steroids or any anti-metabolite therapies within 3 months of entry into the study (inhaled and topical corticosteroids are permitted).
Receipt of any vaccine or immunoglobulin within 30 days before the first dose of study drug. Flu vaccines are only allowed once the subjects are qualified for 36 additional weeks of treatment.
Prior administration of oligodeoxynucleotides (including study medication CPG 10101), ribozymes, or any known allergy to CPG 10101, interferon, RVN or their excipients.
Receipt of any investigational drug therapy within 30 days before the first dose of study drug.
Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: CPG10101 (0.2) + pegylated inteferon + ribavirin
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CPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
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Experimental: CPG10101 (0.5) + pegylated inteferon + ribavirin
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CPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
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Comparador activo: Pegylated interferon + ribavirin
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Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 12wks
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Experimental: CPG10101 + pegylated interferon + ribavirin (rollover)
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CPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Serum HCV RNA concentrations, over 12wks, relative to baseline, early virologic response (EVR)
Periodo de tiempo: 12wks
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12wks
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Serum HCV RNA concentrations, 6months after treatment completed, relative to baseline, sustained virologic response (SVR)
Periodo de tiempo: 72wks
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72wks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Safety and Tolerability: adverse events, vital signs, clinical and laboratory parameters, depression score, physical exam, electrocardiogram (ECG), ophthalmologic exam (if required)
Periodo de tiempo: 28wks
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28wks
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Dose exposure
Periodo de tiempo: 24wks
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24wks
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Child-Pugh score
Periodo de tiempo: 24wks
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24wks
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Serum Biomarkers: cytokines and chemokines, over time, relative to baseline
Periodo de tiempo: 24wks
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24wks
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Immunophenotyping profile, over time, relative to baseline, HCV specific immune response, over time, relative to baseline, level of innate immune activation at baseline
Periodo de tiempo: 24wks
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24wks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis Crónica
Otros números de identificación del estudio
- B1211002
- CPG 10101-004
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Hepatitis Crónica Activa
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Gilead SciencesTerminadoHepatitis Crónica DeltaFrancia, Moldavia, República de, Rumania, Federación Rusa
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Ziauddin HospitalDesconocido
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University of Maryland, BaltimoreAlexandria University; MADAUS GmbH; The Egyptian Company for Blood Transfusion... y otros colaboradoresTerminadoHepatitis C aguda | Hepatitis B aguda | Hepatitis A aguda | Hepatitis E aguda | Hepatitis aguda por VEB | Hepatitis aguda por CMVEgipto
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Eiger BioPharmaceuticalsTerminado
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National Taiwan University HospitalNational Science Council, Taiwan; National Health Research Institutes, TaiwanDesconocidoHepatitis B crónica | Hepatitis D crónicaTaiwán
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Hoffmann-La RocheTerminado
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Hepatera Ltd.TerminadoInfección crónica por hepatitis D
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesAún no reclutando
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Eiger BioPharmaceuticalsRetiradoHepatitis Delta Crónica
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Tokhirbek DolimovDesconocidoHepatitis Crónica Delta | Biopsia hepaticaUzbekistán
Ensayos clínicos sobre CPG10101
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PfizerTerminadoHepatitis Crónica ActivaEstados Unidos