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LAM group

Phase 3

Chronic Hepatitis B | Small molecule | Infectious Disease |GSK plc|Last Updated: Oct 6, 2009

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00316719Adefovir Dipivoxil In Compensated Chronic Hepatitis B PatientsPHASE3 COMPLETED 105Jan 1, 2006Jan 1, 2008Oct 6, 2009 -
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Study Endpoints
Primary Endpoints
Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52
Baseline and Week 52

Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52

Secondary Endpoints
Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52
Week 52
Time to Onset of HBV DNA Loss (< 400 Copies/mL)
From Baseline to Week 52
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52
Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Adefovir Dipivoxil (ADV)EXPERIMENTAL -
Lamivudine (LAM)ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
LAM groupDRUGSubjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
ADV groupDRUGSubjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
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Eligibility Criteria
Age Range16 Years — 64 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Have compensated chronic hepatitis B. * Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted. * Ability to read, understand, and sign the informed consent. * Have a positive serum HBV-DNA \>...

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