A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon
16 de agosto de 2016 actualizado por: Yonsei University
An Observational, Multi-Center, Cohort Study Evaluating the Antiviral Efficacy, Safety, and Tolerability in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon-alpha 2a (Pegasys®): TRACES STUDY
The current proposed study aims to bring answers following issues: the antiviral efficacy and safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected with solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver cirrhosis and liver cancer.
In addition, this study aims to collect more data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in patients with CHB.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
- Korea is known to be an endemic area for HBV infection. Some studies have reported that more than 95% of patients in Korea with chronic HBV have genotype C infection.
- Compared with other genotypes, genotype C is associated with increased viral loads, higher histologic activity, more severe acute exacerbations, a longer viral clearance phase and worse antiviral response to peg-interferon therapy.
- Long-term nucleos(t)ide analogue (NA) therapy is recommended for chronic hepatitis B (CHB) patients with compensated and decompensated liver disease. However, a possibility of cessation of antiviral treatment with oral NAs is unlikely due to rebound of HBV DNA levels after termination of NAs administration. In addition, NA therapy has been reported to have lower chance of HBsAg seroclearance compared to that with immunomodulatory agents such as peginterferon.
- Pegasys® has been proved to induce HBsAg loss, which is the closest to cure of disease. However, a better understanding of HBV treatment with Pegasys® in the real-life clinical setting in Korea can be helpful for decision of treatment strategy in the future. Asian experience with Pegasys® therapy in CHB is limited. Study populations of investigator-initiated trials consist of selected group with smaller number of Korean patients. Therefore, long-term efficacy and safety data in real practice with Pegasys® treatment in both HBeAg-positive and -negative Korean patients are necessary.
- In addition, the current proposed collected data study may be helpful to bring answers to many unresolved issues: the antiviral efficacy and safety profiles in Korean CHB patients who are mostly infected with solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in patients with CHB.
Tipo de estudio
De observación
Inscripción (Actual)
500
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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Seodaemun-gu
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Seoul, Seodaemun-gu, Corea, república de, 120-752
- Sang Hoon Ahn
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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
20 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
HBeAg-positive and HBeAg-negative chronic hepatitis B patients who have completed or are currently on Pegasys® monotherapy as a first line therapy.
In addition, all consecutive CHB patients who will be initiated on Pegasys® in 2011 will be prospectively enrolled.
Descripción
Inclusion Criteria:
- Adult subjects receiving treatment for CHB with PEGASYS according to standard of care and in line with the current summary of product characteristics(SPC)/ local labeling who have no contra-indication to PEGASYS therapy as per the local label.
- Adult chronic hepatitis B patients (20 years of age or older) who has been completed or are currently receiving or are planned to receive Pegasys® as a first-line therapy.
- Those with baseline HBV DNA > 2,000 IU/mL and elevation of ALT level.
- HBeAg positive or HBeAg negative serologically proven chronic hepatitis B(CHB)
- Subjects treated with previous NAs therapy are eligible for this study.
Exclusion Criteria:
Subjects with ALT > 10 x ULN or evidence of hepatocellular carcinoma.
- Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
- Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.
- Subjects should have no other diseases that might be contraindication to peg-interferon therapy as per local SPC (e.g., severe psychiatric diseases, immunological diseases, severe retinopathy or thyroid dysfunction, history of severe pre-existing cardiac disease, etc)
- Subjects with other contra-indications to PEGASYS therapy as detailed in the label (hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
- A history of liver transplantation or planned for liver transplantation
- Subjects who receive concomitant therapy with telbivudine.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Hepatitis B crónica
|
Pegasys 180mcg/PFS/ subcutaneous injection / Once a week
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
HBsAg loss or appearance of anti-HBs antibody in treatment-naïve Korean CHB patients treated with Pegasys
Periodo de tiempo: 2015 (up to 3 years)
|
2015 (up to 3 years)
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Sustained suppression of HBV DNA
Periodo de tiempo: 2015 (up to 3 years)
|
2015 (up to 3 years)
|
|
HBeAg loss and seroconversion in HBeAg-positive CHB
Periodo de tiempo: 2015 (up to 3 years)
|
2015 (up to 3 years)
|
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ALT normalization
Periodo de tiempo: 2015 (up to 3 years)
|
2015 (up to 3 years)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Sang Hoon Ahn, MD. PhD, Department of Internal Medicine, Yonsei Universtiy College of Medicine,
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 septiembre de 2011
Finalización primaria (Actual)
1 de agosto de 2014
Finalización del estudio (Actual)
1 de octubre de 2014
Fechas de registro del estudio
Enviado por primera vez
31 de enero de 2012
Primero enviado que cumplió con los criterios de control de calidad
9 de febrero de 2012
Publicado por primera vez (Estimar)
10 de febrero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de agosto de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
16 de agosto de 2016
Última verificación
1 de agosto de 2016
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
- Hepatitis, Viral, Humana
- Infecciones por Hepadnaviridae
- Infecciones por virus de ADN
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B Crónica
- Hepatitis Crónica
- Efectos fisiológicos de las drogas
- Agentes antiinfecciosos
- Agentes Antivirales
- Agentes antineoplásicos
- Factores inmunológicos
- Interferones
- Interferón-alfa
- Peginterferón alfa-2a
- Interferón alfa-2
Otros números de identificación del estudio
- 4-2011-0461
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