Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
24 de septiembre de 2015 actualizado por: Cheng jun, Beijing Kawin Technology Share-Holding Co., Ltd.
Multi-center, Randomized, Open-label, Parallel-group, Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C
This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated with Interferon.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Total 720 subjects are divided into two groups and treated separately according to the HCV genotype（genotype 2,3 and non-genotype 2,3).
With 2:1 ratio between experimental group and positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled.
Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .
Tipo de estudio
Intervencionista
Inscripción (Actual)
719
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing, Porcelana
- Peking University First Hospital
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Beijing, Porcelana
- Beijing Ditan Hospital, Capital Medical University
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Beijing, Porcelana
- Beijing Youan Hospital, Capital Medical University
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Beijing, Porcelana
- Peking University People's Hospital
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Beijing, Porcelana
- 302 Military Hospital of China
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Beijing, Porcelana
- Beijing Youyi Hospital, capital Medical University
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Beijing, Porcelana
- General Hospital of Beijing Military Region
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Chongqing, Porcelana
- The Second Affiliated Hospital of Chongqing Medical University
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Chongqing, Porcelana
- Chongqing Southwest Hospital
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Shanghai, Porcelana
- Shanghai Public Health Clinical Center
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Tianjin, Porcelana
- Tianjin Infectious Disease Hospital
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Gansu
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Lanzhou, Gansu, Porcelana
- First Affiliated Hospital of Lanzhou University
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Guangdong
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Guangzhou, Guangdong, Porcelana
- Guangzhou Eighth People's Hospital
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Guangzhou, Guangdong, Porcelana
- Nanfang Hospital Southern Medical Unbiversity
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Guangxi
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Nanning, Guangxi, Porcelana
- The First Affiliated Hospital of Guangxi Medical University
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Hebei
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Shijiazhuang, Hebei, Porcelana
- Third Affiliated Hospital, Hebei Medical University
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Heilongjiang
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Harbin, Heilongjiang, Porcelana
- The Second Affiliated Hospital of Harbin Medical University
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Henan
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Xinxiang, Henan, Porcelana
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, Henan, Porcelana
- Henan Provincial People's Hospital
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Hubei
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Wuhan, Hubei, Porcelana
- Tongji Hospital, Tongji Medical College Huazhong University of Science ＆ Technology
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Wuhan, Hubei, Porcelana
- Zhongnan Hospital of Wuhan University
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Wuhan, Hubei, Porcelana
- Union hospital, Tongji Medical College Huazhong University of Science ＆ Technology
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Hunan
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Changsha, Hunan, Porcelana
- The Second Xiangya Hospital of Central South University
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Changsha, Hunan, Porcelana
- Xiangya Hospital Central-South University
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Jiangsu
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Nanjing, Jiangsu, Porcelana
- Jiangsu Province Hospital
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Nanjing, Jiangsu, Porcelana
- The Second Hospital of Nanjing
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Jiangxi
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Nanchang, Jiangxi, Porcelana
- First Affiliated Hospital of Nanchang University
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Jilin
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Changchun, Jilin, Porcelana
- The first Affiliated Hospital of Jilin University
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Yanji, Jilin, Porcelana
- Yanbian University Hospital (Yanbian Hospital)
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Liaoning
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Shenyang, Liaoning, Porcelana
- The Sixth People's Hospital of Shenyang
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Shaanxi
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Xi'an, Shaanxi, Porcelana
- First Affiliated Hospital of Medical College of Xian jiaotong University
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Xi'an, Shaanxi, Porcelana
- Second Affiliated Hospital Of Medical College of Xian Jiaotong University
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Xi'an, Shaanxi, Porcelana
- Tangdu hospital,fourth military medical university
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Shandong
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Jinan, Shandong, Porcelana
- Qilu Hospital of Shandong University
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Jinan, Shandong, Porcelana
- Jinan Infectious Disease Hospital
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Qingdao, Shandong, Porcelana
- Qingdao Municipal Hospital
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Shanxi
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Taiyuan, Shanxi, Porcelana
- The First Hospital of Shanxi Medical University
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Sichuan
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Chengdu, Sichuan, Porcelana
- West China Hospital, Sichuan University
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Chengdu, Sichuan, Porcelana
- Sichuan Academy of Medical Science ＆Sichuan Provincial People's Hospital
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Xinjiang
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Urumqi, Xinjiang, Porcelana
- The First Teaching Hospital of Xinjiang Medical University
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Zhejiang
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Wenzhou, Zhejiang, Porcelana
- The First Affiliated Hospital of Wenzhou Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 18- 65 years
- Body Mass Index (BMI) 18-30
- Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year 2004)
- Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive anti-HCV antibody
- Female subjects of childbearing age with no history of menopause and negative pregnancy test, both female and male( including their partners ) subjects were required to conduct adequate contraception since screening until the 6 months after treatment
- Volunteered to participate in this study, understood and signed an informed consent
Exclusion Criteria:
- Previous IFN treated patients
- Hepatotoxic drugs was systematically used more than two weeks within past 6 months
- Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids
- Co-infection with HAV, HBV, HEV, EBV, CMV and HIV
- Evidences of hepatic decompensation, including but not limited to serum total bilirubin> 2 times the upper limit of normal (ULN); serum albumin <35g/L; prothrombin activity (PTA) <60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade
- Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP> l00ng/ml, suspicious liver nodules by imaging examinations
- Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
- White blood cell count <3×109/L; Neutrophil count<1.5×109/L; platelet count<90×109/L; hemoglobin below the lower limit of normal
- Serum creatinine above the ULN
- Serum creatine kinase> 3 ULN
- Diabetes mellitus or Poorly controlled Thyroid Diseases
- Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood pressure> 90 mmHg) with hypertension -related retinal lesions
- Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
- Psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
- Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias)
- Serious blood disorders (all kinds of anemia, hemophilia, etc.)
- Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
- Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
- Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
- Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
- Malignancies
- Function organs transplant
- Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
- Evidence of alcohol or drug abuse (average alcohol consumption male> 40g / day, female> 20g / day)
- Pregnant or lactating women
- Usage of prohibition drugs in this study
- Participated in other clinical trials 3 months prior to the screening
- Unwilling to sign the informed consent and adhere to treatment requirements
- Other conditions not suitable for study judged by investigators
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: PEG-IFN-SA /RBV T1(Genotype2,3)
PEG-IFN-SA/RBV, 1.5μg/kg/week im and RBV 1000mg-1200mg/d po bid（BW<75kg,1000mg/d; BW≥75kg, 1200mg/d）,24 weeks
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Comparador activo: Pegasys /RBV C1(Genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 24 weeks
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Experimental: PEG-IFN-SA /RBV T2(Non-genotype 2,3)
PEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
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Comparador activo: Pegasys /RBV C2(Non-genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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SVR (sustained virologic response)
Periodo de tiempo: 24 weeks after 24 or 48 weeks of study therapy
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of treatment
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24 weeks after 24 or 48 weeks of study therapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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RVR(rapid virologic response)
Periodo de tiempo: weeks 4 of study therapy
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4
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weeks 4 of study therapy
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cEVR (complete early virologic response)
Periodo de tiempo: weeks 12 of study therapy
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 12
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weeks 12 of study therapy
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ETVR( end of treatment virologic response)
Periodo de tiempo: weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at the end of treatment
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weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
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eRVR ( extended rapid virologic response)
Periodo de tiempo: weeks 4 and 12 of study therapy
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4 and 12
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weeks 4 and 12 of study therapy
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No-responses
Periodo de tiempo: weeks 12 or weeks 24 of study therapy
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defined as the proportion of patients who had less than a <2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24
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weeks 12 or weeks 24 of study therapy
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Breakthrough
Periodo de tiempo: weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
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defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA)
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weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
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Relapse
Periodo de tiempo: 12 and 24 weeks after 24 or 48 weeks of study therapy
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defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then
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12 and 24 weeks after 24 or 48 weeks of study therapy
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Cheng jun, MD, PhD, Beijing Ditan Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2013
Finalización primaria (Actual)
1 de agosto de 2015
Finalización del estudio (Actual)
1 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2013
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2013
Publicado por primera vez (Estimar)
19 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
25 de septiembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
24 de septiembre de 2015
Última verificación
1 de septiembre de 2015
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
- Hepatitis C Crónica
- Agentes antiinfecciosos
- Agentes Antivirales
- Peginterferón alfa-2a
Otros números de identificación del estudio
- KAWIN-002-2
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. .