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telbivudine or lamivudine

Phase 3

Chronic Hepatitis B | Small molecule | Infectious Disease |Novartis AG|Last Updated: Mar 20, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00057265A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis BPHASE3 COMPLETED - — — Feb 1, 2003 -Mar 20, 201511 United States, South Korea +4
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Study Endpoints
Primary Endpoints
Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.
Secondary Endpoints
Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
telbivudine or lamivudineDRUG -
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Eligibility Criteria
Age Range16 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patient is pregnant or breastfeeding * Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HI...

Countries:United StatesSouth KoreaSpainThailandTurkey (Türkiye)United Kingdom
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