EUCTR2010-024586-45-ES进行中（未招募）不适用
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon ?-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon ?-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB) -
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Pacientes que no hayan recibido tratamiento previo con anti-VHB También son elegibles los pacientes que hayan recibido tratamiento con nucleósidos anti-VHB orales durante < 12 semanas, si la última dosis la tomaron 24 semanas antes de la selección.
- •ADN del VHB > 10^5 copias/ml en pacientes HBeAg- y > 10^6 copias/ml en pacientes HBeAg+.
- •ALT > 60 U/l y menor o igual a 400 U/l en varones y > 40 U/l y menor o igual a 300 U/l en mujeres.
- •Aclaramiento de la creatinina mayor o igual a 80 ml/min.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 706
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Fibrosis en puente o cirrosis y/o hepatopatía descompensada conocidas.
- •Indicios de carcinoma hepatocelular.
- •Enfermedades renales, cardiovasculares, pulmonares, neurológicas o autoinmunitarias significativas o enfermedad ósea (p. ej., osteomalacia, osteomielitis crónica, osteogénesis imperfecta, osteocondrosis, fracturas óseas múltiples).
- •Recuento absoluto de neutrófilos < 1.500/mm3, plaquetas < 100.000/mm3, hemoglobina < 10 g/dl (mujeres) o < 11 g/dl (varones).
- •Antecedentes de depresión severa o enfermedad psiquiátrica severa.
- •Disfunción tiroidea.
- •Coinfección con VIH, VHC o VHD.
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon alfa-2a (Pegasys) versus Tenofovir Disoproxil Fumarate or Peginterferon alfa-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects.EUCTR2010-024586-45-ITGILEAD SCIENCE INC.720
进行中（未招募）
1 期
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB).Chronic Hepatitis BMedDRA version: 12.1Level: LLTClassification code 10008910Term: Chronic hepatitis BEUCTR2010-024586-45-FRGilead Sciences Inc.751
进行中（未招募）
4 期
Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a vs Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Chronic Hepatitis B (CHB).CTRI/2012/11/003083Gilead Sciences Inc720
已完成
4 期
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)HBeAg-Positive or HBeAg-Negative Chronic Hepatitis Binfection of the liver10047438NL-OMON39436Gilead Sciences15
进行中（未招募）
不适用
A study in people with long-lasting hepatitis B to assess the effectiveness and safety of a combination of the two drugs Viread and Pegasys compared with each drug given on its own.EUCTR2010-024586-45-DEGilead Sciences Inc.720