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Trial History Detail on 2005-09-05

CUHK_CCT00014

2005-09-05

Retrospective

P03227

Hepatitis Research Fund

Schering-Plough

Angel Chim

Room 36, 2/F, LSK Specialist Clinic South Wing, PWH; Tel: 2632 4205; e-mail: angelchim@cuhk.edu.hk

e-mail

Dr Henry LY Chan

9/F Clinical Science Building, PWH; Tel: 2632 3307; e-mail: hlychan@cuhk.edu.hk

e-mail

A Study on the viral kinetics of different regimes of Pegylated Interferon and Lamivudine combination therapy in HBeAg Positive Chronic Heptatitis B

Yes

2002-08-07

Viral Diseases

Drug

PEG-Intron A 100mcq sc once weekly, Lamivudine 100mg QD

treatment period 104 weeks (include 32 doses of PEG-Intron A and 96 or 104 weeks Lamivudine)

one year treatment of Lamivudine 100mg QD

Inclusion: 18 - 65 years of age; documented serum HBsAg positive for at least 6 months prior to screening; evidnece of HBV replicatioin documented by serum HBV DNA > 10^6 copies per me at screening; serum HBeAg positive at screening; presence of abnormal ALT (1.3-10XULN) at screening; WBC >= 4,000/mm^3; platelets >= 100,000/mm^3; bilirubin normal (except for Gilbert's disease); albumin stable and normal. Exclusion: co-infection with hepatitis C virus and/ or HIV; evidence or history of decompensated liver disease

Randomized

Uncontrolled

Open label

Parallel

2002-12-13

30

Complete

Sustained complete response ¡V normalization of ALT and negative HBV DNA 26 weeks after the cessation of treatment

1. End-of-treatment complete response¡Vnormalization of ALT and negative HBV DNA at the end of treatment. 2. Viral response ¡V negative HBV DNA at the end of treatment and 26 weeks after cessation of treatment. 3. Biochemical response ¡V normalization of ALT at the end of treatment and 26 weeks after the cessaion of treatment. 4. Safety of treatment

No

2011-03-02


Yes

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