Phase 3 study for adefovir dipivoxil in patients with compensated chronic hepatitis B –comparative study with lamivudine
- Conditions
- Hepatitis B, ChronicTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-004890-34-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 100
Male or female patients aged =16 and <65, with serum HBV DNA = 1 x 106 copies/mL at screening; serum alanine aminotransferase (ALT) level 50-500U/L at screening; with no mutation resistant to ADV and LAM at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective: To compare the efficacy and safety of adefovir dipivoxil (ADV) 10mg<br>with lamivudine (LAM) 100mg, once daily for 52 weeks in Japanese patients with<br>compensated chronic hepatitis B who have not been treated with antiviral medication.<br>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<br>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 Outcome Measures
Name Time Method Secondary end point(s): 1) Evaluation of HBV DNA level<br>• Percentage of patients with serum HBV DNA levels below the limit of<br>quantification (HBV DNA loss)<br>• Time to onset of serum HBV DNA loss<br>2) Evaluation of virus markers other than HBV DNA<br>• Percentage of patients with HBeAg loss<br>• Percentage of patients with HBeAg/Ab seroconversion<br>• Time to onset of HBeAg loss<br>• Time to onset of HBeAg/Ab seroconversion<br>• Percentage of patients with HBsAg loss<br>• Percenage of patients with HBsAg/Ab seroconversion<br>3) Liver function tests<br>• ALT level at Week 52 (distribution)<br>• Percentage of patients with normalized ALT<br>• Time to onset of ALT normalization<br>4) Rate of emergence of resistant virus at Week 52 ;Timepoint(s) of evaluation of this end point: 52 weeks