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LdT and lamivudine

Phase 3

Hepatitis B | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Mar 23, 2011

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 Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00275652A Comparison of the Drug Telbivudine (LdT) and Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis.PHASE3 COMPLETED 6Jun 1, 2004Aug 1, 2007Mar 23, 20111 United States
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Study Endpoints
Primary Endpoints
A 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.
Durability of clinical response
Proportion of patients achieving improvement, stabilization, and worsening in CTP score
Proportion of patients with normal ALT
Improvements in serum albumin levels, in patients with hypoalbuminemia pre-treatment
Secondary Endpoints
Time to clinical response
Duration of clinical response
Proportion of patients achieving improvement, stabilization, and worsening in CTP score
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
LdT (Telbivudine) and lamivudineDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Patients with chronic hepatitis b with evidence of cirrhosis, who are at least 18 to 70 years old, may be eligible to participate in this study.

Countries:United States
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