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Trial History Detail on 2009-11-19

CUHK_CCT00013

2005-09-05

Retrospective

Hepatitis Research Fund

Roche Hong Kong Limited

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

Treatment with Peginterferon Alfa-2a (40 KD) (PEGASYS®) of Chronic Hepatitis B Patients, Who Have Failed Anti-Viral Treatment? A Pilot Study

Yes

2005-01-03

Viral Diseases

Drug

Peginterferon Alfa-2a (40 KD) (PEGASYS®) 180 mcq per week

48 weeks

one year treatment of Lamivudine 100mg QD

Inclusion: age 18-70; HBsAg positive for more than 6 months and detectable HBV DNA; previous use of nucleostide analogue for at least 12 months and the treatment has been stopped for at least 6 months; elevated serum ALT > 1.5X ULN but <= 10X ULN as determined by two abnormal values taken >= 14 days apart during the 6 months before the first dose of study drug with at least one of the determinations obtained during the sreening period.

Exclusions: evidence of decompensated liver disease, HCC, pre-existing severe depression or other psyciatric disease, significant cardiac, significant renal disease, seizure disorder or severe retinopathy; positive test at screening for HIV or HCV; serum total bilirubin > 3X ULN at screening; neutrophil count < 1500 cells/mm^3 or platelet count < 90,000 cells/mm^3 at screening; hemoglobin < 11.5g/dL for females and < 12.5 g/dL for men at screening; serum creatinine level > 120umol/ml for men and > 105 umol/ml for women at screening

Non-randomized

Placebo

Open label

Parallel

2005-04-15

49

Recruiting

- HBeAg positive patients response is defined as HBeAg loss and presence of anti-HBe (HBeAg seroconversion). - HBeAg Negative patients response is defined as DNA<20,000 copies/ml and ALT normalization both measured at week 72.

1. Percentage of patients with HBV DNA levels <100,000 copies/ml at week 72. 2. Percentage of patients with HBV DNA levels <10,000 copies/ml at week 72 3. Percentage of patients with HBV DNA levels negative by PCR at week 72. 4. ALT normalization at week 72. 5. HBsAg seroconversion at week 72. 6. Safety of treatment

No

2011-03-02


Yes

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