Hepatitis B, Chronic
Conditions
Interventions
Trade Name: Zeffix
Pharmaceutical Form: Tablet
INN or Proposed INN: LAMIVUDINE
CAS Number: 134678-17-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmac
Sponsors
GlaxoSmithKline K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients aged =16 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Liver cancer (including both primary and metastatic); co-infection with HCV or HIV; autoimmune hepatitis (ex. antinuclear titer > 1:160) rather than chronic hepatitis B; a history of transplantation or having a plan for any transplantation; serious complication (e.g., cancer, serious cardiopulmonary disease, uncontrolled diabetes, alcoholism) other than hepatitis B; treatment with overdose NSAIDs, excluding temporary or topical use, within the past 7 days; receiving injection containing glycyrrhizin as the main component (e.g. monoammonium glycyrrhizinate/glycine/Lcystein hydrochloride) within the past 4 weeks; treatment with following drugs (except ointment and/or cream etc.) within the past 8 weeks: drugs causing renal impairment, competitors of renal excretion (except temporary use), immunosuppressants, glucocorticoid preparations, drugs causing hepatic impairment; IFNs or HB vaccine within the past 24 weeks; a history of hypersensitivity to nucleoside analogues; pregnant, possibly pregnant or lactating females, or females who wish to be pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To compare the efficacy and safety of adefovir dipivoxil (ADV) 10mg with lamivudine (LAM) 100mg, once daily for 52 weeks in Japanese patients with compensated chronic hepatitis B who have not been treated with antiviral medication. For efficacy, to test the non-inferiority of ADV against LAM.;Secondary Objective: Secondary objective: To compare the efficacy of ADV in monotherapy in this study to these in overseas studies (Studies GS-98-437 and GS-98-438).;Primary end point(s): Change from baseline in serum HBV DNA level at Week 52;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Evaluation of HBV DNA level • Percentage of patients with serum HBV DNA levels below the limit of quantification (HBV DNA loss) • Time to onset of serum HBV DNA loss 2) Evaluation of virus markers other than HBV DNA • Percentage of patients with HBeAg loss • Percentage of patients with HBeAg/Ab seroconversion • Time to onset of HBeAg loss • Time to onset of HBeAg/Ab seroconversion • Percentage of patients with HBsAg loss • Percenage of patients with HBsAg/Ab seroconversion 3) Liver function tests • ALT level at Week 52 (distribution) • Percentage of patients with normalized ALT • Time to onset of ALT normalization 4) Rate of emergence of resistant virus at Week 52 ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed