Last updated: 11/07/2018 17:32:06
An open, randomised, multicentre, phase II study to evaluate the safety and therapeutic efficacy of an investigational vaccination regimen versus Lamivudine in adult patients with HBeAg positive chronic Hepatitis B.Lamivudine (Lam): GlaxoSmithKline (GSK) Biologicals’ cytosine nucleoside analogue…
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open, randomised, multicentre, phase II study to evaluate the safety and therapeutic efficacy of an investigational vaccination regimen versus Lamivudine in adult patients with HBeAg positive chronic Hepatitis B.Lamivudine (Lam): GlaxoSmithKline (GSK) Biologicals’ cytosine nucleoside analogue…
Trial description: An open, randomised, multicentre, phase II study to evaluate the safety and therapeutic efficacy of an investigational vaccination regimen versus Lamivudine in adult patients with HBeAg positive chronic Hepatitis B.Lamivudine (Lam): GlaxoSmithKline (GSK) Biologicals’ cytosine nucleoside analogue…
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Vandepapelière P et al. (2007) Therapeutic vaccination of chronic hepatitis B patients with virus suppression by antiviral therapy: A randomized, controlled study of co-administration of HBsAg/AS02 candidate vaccine and lamivudine - Vaccine 25: 8585–8597
Medical condition
Hepatitis B
Product
lamivudine
Collaborators
Not applicable
Study date(s)
September 2000 to May 2003
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-20-05
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
Not applicable
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