Last updated: 11/07/2018 17:53:27
A randomised, stratified, double-blind, multicentre study of the safety and efficacy of 52 weeks treatment with adefovir dipivoxil and lamivudine for subjects with chronic hepatitis B who have developed hepatitis B virus variants and evidence of reduced therapeutic response to lamivudine
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, stratified, double-blind, multicentre study of the safety and efficacy of 52 weeks treatment with adefovir dipivoxil and lamivudine for subjects with chronic hepatitis B who have developed hepatitis B virus variants and evidence of reduced therapeutic response to lamivudine
Trial description: A randomised, stratified, double-blind, multicentre study of the safety and efficacy of 52 weeks treatment with adefovir dipivoxil and lamivudine for subjects with chronic hepatitis B who have developed hepatitis B virus variants and evidence of reduced therapeutic response to lamivudine
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:
Perrillo R, Hann HW, Mutimer D, et al. Adefovir Dipivoxil Added to Ongoing Lamivudine in Chronic Hepatitis B with YMDD Mutant Hepatitis B Virus. Gastroenterology 2004;126:81-90.
Medical condition
Hepatitis B, Chronic
Product
lamivudine
Collaborators
Not applicable
Study date(s)
February 2000 to February 2002
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
Clinical study report
Available language(s): English
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
2002-27-02
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
Not applicable
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