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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00338780
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : October 30, 2006
Information provided by:
Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE June 19, 2006
First Posted Date  ICMJE June 20, 2006
Last Update Posted Date October 30, 2006
Study Start Date  ICMJE November 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2006)
Proportion of patients with complete response (normalisation of LAT, ie. <1xULN and disappearance of HBV DNA, lower limit of detection), at MOnth 24
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00338780 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2006)
  • Proportion of patients with partial response
  • Histological improvement at month 24
  • Proportion of patients with complete response post-treatment (at Month 30)
  • Proportion of patinets with partial response post-treatment (at Month 30)
  • Progression of fibrosis
  • Progression of fibrosis to cirrhosis
  • HBsAg seroconversion
  • Safety of treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients (in Asia)
Official Title  ICMJE A Randomised, Double-Blinded, Placebo-Controlled Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients (in Asia)
Brief 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
Detailed Description

Recent studies have proved lamivudine a very potent antiviral drug in suppressing viral replication and improving hepatic necro-inflammation with minimal adverse effects in HBeAg positive chronic hepatitis B patients. The efficacy of lamivudine in HBeAg positivce Asian patients has been weel established. However, the evidence in HBeAg negative patients is limited.

In the absence of HBeAg seroconversion, guidance on the clinical management of HBeAg negative hepatitis B patitents treated with lamivudine and data on the efficacy of lamivudine in controlling pre-core HBV disease long-term is still needed. Existing data in HBeAg negative/ HBV DNA positive HBV demonstrate clear and statisticallysignificant serological benefit of lamivudine over placebo during treatment. Limited sustained response was observed post-treatment following a one year treatment period. Whether these results can be applied to patients in Asia is uncertain. This study is therefore intended to further assess te efficacy profile over an extended treatment period in the Asian population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE Drug: Lamivudine/ Placebo 100mg daily
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00338780
Other Study ID Numbers  ICMJE NUC30934
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Joseph JY Sung, PhD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP