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ACH-126,443

Phase 2

Hepatitis B, Chronic | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Feb 18, 2021

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00034359Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus InfectionPHASE2 COMPLETED 79Feb 1, 2002Jan 1, 2003Feb 18, 20213 Bulgaria, Federal Republic of Yugoslavia
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
ACH-126,443DRUG -
LamivudineDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months. * Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter. * Hepatitis B e-antigen positive. * Human immunodeficiency virus negative. * Basic hematologic and chem...

Countries:BulgariaFederal Republic of Yugoslavia
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