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Trial History Detail on 2011-02-08

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 e-mail: angelchim@cuhk.edu.hk

Dr Henry LY Chan

9/F Clinical Science Building, PWH; ;

Tel: 2632 3307

e-mail e-mail: hlychan@cuhk.edu.hk

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 - normalization of ALT and negative HBV DNA 26 weeks after the cessation of treatment

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

No

2011-03-02

ChiCTR-TRC-09000638

2010-05-04


Yes

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