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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

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

DV-601 · 1 trial · 1 indication

Phase 1 1
NCT01023230A Study to Assess DV-601 in Subjects With Chronic Hepatitis BHepatitis B, Chronic
COMPLETED14 Analytics
PHASE1COMPLETED
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
Hepatitis B, ChronicUnlock trial analytics

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 to 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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Frequently asked questions about DV-601

What is DV-601 used for?

DV-601 is an investigational small molecule being developed for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development and has been studied in a completed trial involving 14 subjects with chronic Hepatitis B.

Who makes DV-601?

DV-601 is being developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DVAX. The drug is currently in Phase 1 clinical development for chronic Hepatitis B.

What phase is DV-601 in?

DV-601 is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT01023230, which enrolled 14 subjects with chronic Hepatitis B. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is DV-601 in?

DV-601 has been studied in one completed Phase 1 clinical trial, NCT01023230, titled 'A Study to Assess DV-601 in Subjects With Chronic Hepatitis B.' The trial enrolled 14 subjects in Poland and was not randomized, double-blind, or controlled.

Is DV-601 a small molecule?

Yes, DV-601 is a small molecule therapeutic. It is being developed by Dynavax Technologies Corporation for the treatment of chronic Hepatitis B, an infectious disease. The drug is currently in Phase 1 clinical development.