Table E16Completed unpublished RCTs in patients with chronic hepatitis B

SponsorIDTested DrugPhaseDesignOutcomes
Mayo Clinic; Idenix PharmaceuticalsNCT00275652LdT (Telbivudine) and lamivudinePhase 3Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy StudyA composite endpoint called “clinical response” which is defined as HBV DNA <10 4 copies/ml and normal ALT and improvement, or stabilization in CTP score.
Improvement, stabilization, and worsening in CTP score; normal ALT; improvements in serum albumin levels, in patients with hypoalbuminemia pre-treatment
GlaxoSmithKlineNCT00316719Adefovir dipivoxilPhase 3Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy StudyChange in serum HBV-DNA level from baseline to week 52
HBV-DNA level; ALT level and proportion of patients achieving ALT normalization; Emergence rate of resistant virus
Idenix Pharmaceuticals; NovartisNCT00124241Telbivudine
lamivudine
Phase 2Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy StudyNot reported
Bristol-Myers Squibb; Bristol-Myers SquibbNCT00096785Entecavir
adefovir
Phase 3Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy StudyAntiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR(log10 copies/mL)
Exploratory viral kinetics: HBV DNA by PCR<LOQ and normalization of ALT (<1×ULM). Relapse during 24-week post-dosing phase for those who achieve Response. Safety: Number and percentage of subjects with AEs, lab abnormalities and discontinuations due to AEs
Valeant Pharmaceuticals North America; Valeant Pharmaceuticals North AmericaNCT00230503Pradefovir mesylate
adefovir dipivoxyl
Phase 2Randomized, Open Label, Active Control, Parallel Assignment, Safety StudySafety: Clinical examinations of laboratory tests
Change in viral load over time
Undetectable viral load
University of Washington; Gilead Sciences; GlaxoSmithKlineNCT00230477Hepsera
Hepsera and lamivudine
Phase 4Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy StudyDecrease in the viral DNA
HBeAg conversion
National Taiwan University Hospital; Schering-PloughNCT00275938Interferon alpha 2b plus ribavirin
interferon alpha 2b plus placebo
Phase 2/Phase 3Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy StudyUndetected serum HBV DNA level (i.e., less than 2.5 pg/ml) at the end of the 24-week followup period
HBV DNA level at the end of treatment
Clearance of HBeAg and rate of ALT normalization both at the end of the 32-week treatment period and at the end of the 24-week followup
GlaxoSmithKline; Schering-PloughNCT00140725Lamivudine plus Polyethylene glyco-interferon alfa 2b
Lamivudine
Phase 3Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy StudyHBeAg seroconversion to anti-HBe
Normalization of ALT
Undetectable HBV DNA
Histologic improvement
Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment
Achillion PharmaceuticalsNCT00034359ACH-126, 443 (beta-L-Fd4C)Phase 2Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy StudyNot reported
Idenix Pharmaceuticals; NovartisNCT00132652Lamivudine
Telbivudine
Phase 3Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy StudyNot reported
Chinese University of Hong Kong; GlaxoSmithKlineNCT00338780Lamivudine/Placebo 100mg dailyPhase 4Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy StudyComplete response (ALT<17×ULN and disappearance of HBV DNA, lower limit of detection)
Histological improvement at month 24
Progression of fibrosis
Progression of fibrosis to cirrhosis
HBsAg seroconversion
Safety of treatment

From: Appendix E Tables and Figures

Cover of Management of Chronic Hepatitis B
Management of Chronic Hepatitis B.
Evidence Reports/Technology Assessments, No. 174.
Wilt TJ, Shamliyan T, Shaukat A, et al.

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