An Open Label, Multi Centre Phase IV Study of Adefovir Dipivoxil in Korean Patients With Chronic Hepatitis B (CHB)
Status:
Completed
Trial end date:
2006-04-28
Target enrollment:
Participant gender:
Summary
Objective(s) The primary study objective is to assess the antiviral effect of 12 weeks of
adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated
liver disease. The secondary study objectives are to assess the antiviral effect, clinical
benefit and safety of 52 weeks of adefovir dipivoxil treatment.
Endpoint(s) The primary efficacy endpoint is "Mean log10 reduction in serum HBV DNA level
from baseline to Week 12".
The secondary efficacy endpoints include (a) the proportion of patients achieving serum ALT
normalization at Week 52, (b) other assessments of antiviral effects (the proportion of
patients achieving HBV DNA no less than 300 copies per mL at Week 52), (c)HBeAg loss, HBeAg
seroconversion, HBsAg loss and HBsAg seroconversion, (d)the proportion of patients achieving
serum ALT normalization at Week 12.
Study Design This is an open label, multi centre phase IV study for Korean patients with
chronic hepatitis B and compensated liver disease, assessing the antiviral effect of 12 weeks
treatment of Adefovir dipivoxil as a primary objective and antiviral effect, clinical benefit
and safety of 52 weeks treatment as secondary objectives.
Patients will be screened for eligibility criteria and the baseline visit for the treatment
initiation should occur no more than 4 weeks after screening. Total treatment period will be
52 weeks and patients will return to the clinic for assessments as scheduled during treatment
period. After the 52 week study period, it is likely that the patient will benefit from
continued treatment with commercial adefovir. If in the investigator's clinical judgement
this is the case, the investigator should ensure that a routine prescription is available in
a timely manner, and that no unnecessary interruption in treatment occurs.
Study Population A minimum of 100 male or female Korean patients more than 18 years of age
with HBeAg positive chronic hepatitis B and compensated liver disease who meet the
eligibility criteria will be enrolled.
Study Assessments and Procedures
Potential patients will be screened prior to study entry and eligible patients who have given
their consent will have further baseline assessments. Following the screening, the first
doses of study medications will be given at baseline and patients will return to the clinic
for assessment as scheduled during treatment period. Patients who discontinue treatment
prematurely will be followed up every 4 weeks for 12 weeks following the withdrawal visit.
The following key assessment and or measurement will be made at one or more visits during the
study. (See section 14.1 Appendix 1. Time and event schedule):
- Pregnancy test (females of child-bearing potential only)
- Haematology and serum chemistry profile including prothrombin time(PT) and AFP
- HBV DNA (Roche COBAS AMPLICOR HBV MONITOR Test, LLOD 300 copies per ml)
- Hepatitis B markers: HBeAg(Anti HBe will be tested if HBeAg is negative), HBsAg(Anti HBs
will be tested if HBsAg is negative) Investigational Product(s) Adefovir dipivoxil 10mg
tablets will be supplied by GlaxoSmithKline and presented as a white to off white, round
tablets, packaged in the bottle containing 30 tablets