Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients (in Asia)

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim is to investigate whether Lamivudine 100mg daily is effective in the long term treatment of HBeAg negative chronic HBV infected patients with active liver disease in Asia

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborator: GlaxoSmithKline
• Treatments: Lamivudine

Criteria

Inclusion Criteria:

• Age=>18 years

• HBsAg positive and HBeAg negative for at least 6 months prior to screening

• Serum HBV-DNA postiviet, HBeAg negative and HBeAb positive at the same timepoint on at least one occasion during the last 6 months

• ALT >1.5 to 10 x upper limit of normal for at least two occasions within the previous 6 months and at screening, or ALT > upper limit normal and with at least one biochemical flare-up (ALT > 200IU/l) in the last 12 months.

• Informed writted consent

• Liver biopsy material/ slides taken within the previous 12 months, and at least 5 months after any previous antiviral treatment which show evidence of active liver disease (ie. evidence of necroinflammatory activity)

• Written informed consent

Exclusion Criteria:

• Hepatocellular carcinoma

• ALT > 10xULN at screening or history of acute exacerbation leading to transient decompensation

• Serum hepatitis C, hepatitis D or HIV

• Decompensated liver desease as indicated by any of the following: serum bilirubin >3mg/dL, prothrombin time >=2 seconds prolonged above upper limit of reference range, serum albumin <28g/L, history of variceal haemorrhage, presence of intractable ascites at the screening assessment.

• Encepalopathy

• Planned for liver transplantation or previous liver transplantation

• Evidence of autoimmune hepatitis

• Amylase and/ or lipase > 2 times upper limit of reference range

• Serum creatinine >1.5 times upper limit of reference range

• Haemoglobin < 11g/dL

• WBC count <3x10^9/L

• Platelets <100x10^9

• Serious concurrent medical illness other than hepatitis B

• Use of immunosuppressive therapy, immunomodylatory therapy or chronic antiviral thgerpay with other agents within the previous 6 months or during the study

• Previous treatment with lamivudine or famciclovir within the last 6 months

• History of hypersensitivity to nucleoside analogues

• Women of childbearing potential not practising adequate contraception

• Pregnancy or lactation

• Receipt of any investigational drug within 30 days of the first dose of study drug

• Child-Pugh class B or C cirrhosis