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pradefovir

Phase 2

Hepatitis B, Chronic | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: Jun 22, 2012

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment220
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00230503Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis BPHASE2 COMPLETED 220Jun 1, 2004Dec 1, 2006Jun 22, 2012 -
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Study Endpoints
Primary Endpoints
- Safety: Clinical examinations of laboratory tests
- Efficacy: Change in viral load over time
Secondary Endpoints
- Efficacy: Proportion of patients with undetectable viral load
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
pradefovir mesylateDRUG -
adefovir dipivoxylDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Compensated chronic HBV Infection * No prior treatment with adefovir dipivoxil * No interferon or lamivudine treatment for three months prior to enrollment * HBeAg positive or negative * HBV DNA viral load greater than 500,000 copies per mL * ALT between 1.2 and 10 times ULN ...

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