At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 80 enrolled
Drug / intervention
adefovir dipivoxil 10mgdrug
Likely dose
Adefovir dipivoxil 10 mgAI-extracted
Key inclusion· 2
- ✓Completed ADF 103814 trial and continued adefovir dipivoxil treatment without interruption prior to enrollment
- ✓Willing and able to provide written informed consent
Key exclusion· 11
- ✕Current use of more than 5mg prednisolone (or equivalent) per day, immunomodulatory therapy including interferon or thymosin, or systemic cytotoxic agents
- ✕Previous or current lamivudine or antiviral therapy
- ✕Clinical signs of decompensated liver disease
- ✕Inadequate haematological function
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Open Label, Single Arm, Multicenter, Extension Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
In Brief
A Phase 4 clinical trial evaluating adefovir dipivoxil 10mg for Hepatitis B, Chronic and Chronic Hepatitis B. Completed, enrolled 80 participants across 1 site.
Detailed Summary
This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of long term (up to 3 years) adefovir dipivoxil 10mg therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic, Chronic Hepatitis B
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedNov 2006
Primary CompletionApr 2008
TodayJul 2026
First PostedNov 27, 2006
Enrollment StartJul 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.6 years ago
Interventions
adefovir dipivoxil 10mgdrug