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DV-601

Phase 1

Hepatitis B, Chronic | Small molecule | Infectious Disease |Dynavax Technologies Corporation|Last Updated: Apr 16, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01023230A Study to Assess DV-601 in Subjects With Chronic Hepatitis BPHASE1 COMPLETED 14Sep 1, 2009May 1, 2011Apr 16, 20194 Poland
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Study Endpoints
Primary Endpoints
Patient diaries, adverse events, physical exams, and lab tests
Through Day 99
Secondary Endpoints
HBV-DNA levels
Change from baseline to Days 43 and 99, and to Weeks 24 and 48
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DV-601EXPERIMENTAL -
Interventions
NameTypeDescription
DV-601DRUGSix injections of DV-601 administered over a period of 12 weeks.
EntecavirDRUGDaily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Male and female subjects 18 to 65 years of age. * Signed informed consent. * Diagnosis of CHB and candidates for therapy * Normal renal function * Women of childbearing potential must have a serum negative pregnancy test at screening. Women of childbearing potential and males ...

Countries:Poland
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