Finite duration treatment in pre-cirrhotic chronic hepatitis B virus (HBV) infection: Phase IV study of Lamivudine priming of Pegasys treatment in HBeAg positive patients - Hip 1

Southampton University Hospitals NHS Trust0 个研究点目标入组 36 人开始时间: 2006年2月6日最近更新: 2012年3月19日

适应症

试验速览

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•To be eligible for this study, patients must have the following documented:
•1.Age > 18 years
•2.Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA (patients must have >100,000 iu/ml (>500,000 copies/ml) as measured by PCR)
•3.Elevated serum ALT > 1.1 x ULN but < 10X ULN
•4.A liver biopsy obtained within the past 18 months (and more than 6 months after the end of any previous therapy for hepatitis B) demonstrating liver disease consistent with pre-cirrhotic chronic hepatitis B.
•5.Negative urine pregnancy test (for women of childbearing potential) documented within the 48-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•·Histological or clinical evidence of established cirrhosis
•·HIV co-infection (written consent will be taken for the HIV testing and counselling offered)
•·HCV or HDV co-infection
•·Renal impairment: serum creatinine >1.5 ULN
•·Neurological/psychiatric disorder
•·Severe cardiac or pulmonary disease
•·History or other evidence of severe retinopathy
•·Severe seizure disorder or current anti-convulsant use
•·Active or suspected cancer or a history of malignancy where the risk of recurrence is greater than 20% within 2 years.
•·Any other significant systemic disease, including thyroid disease
•·Unable to conform to study protocol due to alcohol use in excess of 20gms/day or drug abuse
•·Alcohol abuse [alcohol in excess of safe limits of 28 units/ week for men and 21 units/week for women] and/or intravenous drug abuse within 1 year of entry
•·A medical condition associated with chronic liver disease other than viral hepatitis
•·Neutrophil count <1,500 cells/ml or platelet count < 100,000 cells/ml
•·Albumin < lower limit of normal
•·Serum alphafetoprotein >2 x ULN
•·Anti-viral treatment with interferon alpha or nucleoside analogue within 18 months
•·Previous treatment with Lamivudine for > 12 months
•·Evidence of emergence of Lamivudine resistant HBV
•·Any research study within previous 3 months

发起方

Southampton University Hospitals NHS Trust