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Chronic Hepatitis BPhase 4NCT00338780

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

A Phase 4 study of Chronic Hepatitis B, run by Chinese University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis B
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
Not given
Where
1 siteChina
Study dates
Nov 2000to Jan 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong SAR

Other trials in China

About this study

Official title: A Randomised, Double-Blinded, Placebo-Controlled Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients (in Asia)

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

Read the 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.

Being tested
Lamivudine/ Placebo 100mg daily
Keywords
Chronic Hepatitis B, Lamivudine, HBeAg negative
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lamivudine/ Placebo 100mg dailyDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with complete response (normalisation of LAT, ie. <1xULN and disappearance of HBV DNA, lower limit of detection), at MOnth 24

Secondary outcomes (8)

  1. Proportion of patients with partial response

  2. Histological improvement at month 24

  3. Proportion of patients with complete response post-treatment (at Month 30)

  4. Proportion of patinets with partial response post-treatment (at Month 30)

  5. Progression of fibrosis

  6. Progression of fibrosis to cirrhosis

  7. HBsAg seroconversion

  8. Safety of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2006 (estimated)
  2. Study startNov 2000
  3. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00338780
Sponsor's protocol ID
NUC30934
Status last verified
Oct 2006
First submitted
19 Jun 2006
Last updated
30 Oct 2006
Results posted
No

Publications

  • Tassopoulos NC, Volpes R, Pastore G, Heathcote J, Buti M, Goldin RD, Hawley S, Barber J, Condreay L, Gray DF. Efficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Lamivudine Precore Mutant Study Group. Hepatology. 1999 Mar;29(3):889-96. doi: 10.1002/hep.510290321.

    PubMed 10051494

  • Maynard JE. Hepatitis B: global importance and need for control. Vaccine. 1990 Mar;8 Suppl:S18-20; discussion S21-3. doi: 10.1016/0264-410x(90)90209-5.

    PubMed 2139281

  • Tu H, Xiong SD, Trepo C, Wen YM. Frequency of hepatitis B virus e-minus mutants varies among patients from different areas of China. J Med Virol. 1997 Feb;51(2):85-9. doi: 10.1002/(sici)1096-9071(199702)51:23.0.co;2-n.

    PubMed 9021537

  • Tu H, Li PY, Wen YM. Anti-HBe titre in patients infected with wild-type and e-minus variant of hepatitis B virus. Res Virol. 1996 Jan-Feb;147(1):39-43. doi: 10.1016/0923-2516(96)80238-x.

    PubMed 8882339

  • ter Borg F, ten Kate FJ, Cuypers HT, Leentvaar-Kuijpers A, Oosting J, Wertheim-van Dillen PM, Honkoop P, Rasch MC, de Man RA, van Hattum J, Chamuleau RA, Reesink HW, Jones EA. Relation between laboratory test results and histological hepatitis activity in individuals positive for hepatitis B surface antigen and antibodies to hepatitis B e antigen. Lancet. 1998 Jun 27;351(9120):1914-8. doi: 10.1016/s0140-6736(97)09391-4.

    PubMed 9654258

  • Brunetto MR, Giarin MM, Oliveri F, Chiaberge E, Baldi M, Alfarano A, Serra A, Saracco G, Verme G, Will H, et al. Wild-type and e antigen-minus hepatitis B viruses and course of chronic hepatitis. Proc Natl Acad Sci U S A. 1991 May 15;88(10):4186-90. doi: 10.1073/pnas.88.10.4186.

    PubMed 2034663

  • Chu CM, Yeh CT, Chiu CT, Sheen IS, Liaw YF. Precore mutant of hepatitis B virus prevails in acute and chronic infections in an area in which hepatitis B is endemic. J Clin Microbiol. 1996 Jul;34(7):1815-8. doi: 10.1128/JCM.34.7.1815-1818.1996.

    PubMed 8784599

  • Chan HLY, Hui Y, Ching JYL, Leung NWY, Chan FKL, Sung JJY. Can we predict disease activity in chronic hepatitis B virus (CHB) infected patients with negative HBeAg. Gastroenterology 1999; 116: A1195

  • Chan HLY,Ghany MC, Lok ASF. Hepatitis B. In Schiff ER, Sorrell MF, Madrey WC, Eds. Schiff's Deseases of the LIver, 8th ed. Lippincott-Raven Publishers, New York, 1998:757-92

  • Zaaijer HL, ter Borg F, Cuypers HT, Hermus MC, Lelie PN. Comparison of methods for detection of hepatitis B virus DNA. J Clin Microbiol. 1994 Sep;32(9):2088-91. doi: 10.1128/jcm.32.9.2088-2091.1994.

    PubMed 7814529

  • Laras A, Koskinas J, Avgidis K, Hadziyannis SJ. Incidence and clinical significance of hepatitis B virus precore gene translation initiation mutations in e antigen-negative patients. J Viral Hepat. 1998 Jul;5(4):241-8. doi: 10.1046/j.1365-2893.1998.00109.x.

    PubMed 9751010

  • Chan HL, Hussain M, Lok AS. Different hepatitis B virus genotypes are associated with different mutations in the core promoter and precore regions during hepatitis B e antigen seroconversion. Hepatology. 1999 Mar;29(3):976-84. doi: 10.1002/hep.510290352.

    PubMed 10051506

  • Krajden M, Minor J, Cork L, Comanor L. Multi-measurement method comparison of three commercial hepatitis B virus DNA quantification assays. J Viral Hepat. 1998 Nov;5(6):415-22. doi: 10.1046/j.1365-2893.1998.00129.x.

    PubMed 9857351

  • Lai VC, Guan R, Wood ML, Lo SK, Yuen MF, Lai CL. Nucleic acid-based cross-linking assay for detection and quantification of hepatitis B virus DNA. J Clin Microbiol. 1999 Jan;37(1):161-4. doi: 10.1128/JCM.37.1.161-164.1999.

    PubMed 9854083

  • Chan HLY, Leung NY, Lau TCM, Wong ML, Sung JJY. Comparison of three different hepatitis B virus (HBV) DNA assays in monitoring of anti-viral therapy. Hepatology 1999 (in press)

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Chronic Hepatitis B, run by Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with complete response (normalisation of LAT, ie. <1xULN and disappearance of HBV DNA, lower limit of detection), at MOnth 24. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00338780, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2006.

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