Last updated: 11/07/2018 17:55:26
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised trial of lamivudine plus interferon versus lamivudine for the treatment of HBeAg positive chronic hepatitis B virus (HBV)
Trial description: This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b
Drug: Lamivudine
Enrollment:
160
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Chan HL-Y, Leung NW-Y, Hui AY, et al. A Randomized, Controlled Trial of Combination Therapy for Chronic Hepatitis B: Comparing Pegylated Interferon ?2b and Lamivudine with Lamivudine Alone. Annals of Internal Medicine 2005:142 (4):240-251.
Medical condition
Chronic Hepatitis B
Product
lamivudine
Collaborators
Not applicable
Study date(s)
March 2000 to February 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
No
- Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
- Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.
- Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.
Inclusion and exclusion criteria
Inclusion criteria:
- Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
- Documented presence of abnormal alanine aminotransferase (ALT) (1.3
- 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.
Exclusion criteria:
- Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-23-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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