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Lamivudine

Phase 3

Chronic Hepatitis B | Small molecule | Infectious Disease |Novartis AG|Last Updated: Feb 23, 2017

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 Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00132652Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis BPHASE3 COMPLETED 240Feb 1, 2005Dec 1, 2006Feb 23, 201714 United States, Australia +9
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
LamivudineDRUG -
TelbivudineDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Documented clinical history compatible with chronic hepatitis B * Patient has compensated liver disease * Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months Other protocol-defined inclusion criteria may appl...

Countries:United StatesAustraliaCanadaChinaFranceIsraelNew ZealandSingaporeTaiwanThailandUnited Kingdom
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