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
The Chinese University of Hong Kong
Dr Henry LY Chan
9/F Clinical Science Building, PWH; ;
Tel: 2632 3307
e-mail e-mail: hlychan@cuhk.edu.hk
The Chinese University of Hong Kong
A Study on the viral kinetics of different regimes of Pegylated Interferon and Lamivudine combination therapy in HBeAg Positive Chronic Heptatitis B
-
-
Hong Kong
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
18
65
Both Male and Female
Interventional
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
2011-03-02
ChiCTR-TRC-09000638
2010-05-04
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