Last updated: 11/07/2018 17:53:52
A double-blind, active-controlled, randomized 52-week extended follow-on study to investigate the long-term efficacy and safety of adefovir dipivoxil 10mg and lamivudine 100mg treatment for subjects with hepatitis B who have completed the previous Phase II protocol NUC20904
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 double-blind, active-controlled, randomized 52-week extended follow-on study to investigate the long-term efficacy and safety of adefovir dipivoxil 10mg and lamivudine 100mg treatment for subjects with hepatitis B who have completed the previous Phase II protocol NUC20904
Trial description: A double-blind, active-controlled, randomized 52-week extended follow-on study to investigate the long-term efficacy and safety of adefovir dipivoxil 10mg and lamivudine 100mg treatment for subjects with hepatitis B who have completed the previous Phase II protocol NUC20904
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, Willems B, Leung N et al. Continued safety and efficacy of adding adefovir dipivoxil (ADV) to ongoing lamivudine (LAM) therapy in compensated chronic hepatitis B (CHB) patients with YMDD variant HBV: 2 year results. J Hepatol 40 (Suppl 1) Abstract 438.
Medical condition
Hepatitis B
Product
lamivudine
Collaborators
Not applicable
Study date(s)
May 2001 to June 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
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
2003-03-06
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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