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adefovir dipivoxil

Phase 3

Hepatitis B, Chronic | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

adefovir dipivoxil · 1 trial · 1 indication

Phase 3 1
NCT00661076ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis BHepatitis B, Chronic
COMPLETED10 Analytics
PHASE3COMPLETED
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
Hepatitis B, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

Normalization of ALT, and HBV-DNA <400 copies/mL
Week 96 for arm 1; week 48 for arms 2 and 3
HBsAg quantitative loss and anti-HBs seroconversion
Weeks 48, 96 and 144

Secondary Endpoints

AEs, lab parameters, vital signs
Throughtout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
adefovir dipivoxilDRUG10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
peginterferon alfa-2a [Pegasys]DRUG180 micrograms weekly for 48 weeks
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * adult patients, 18-70 years of age; * chronic hepatitis B; * positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months; * either nucleoside analogue naive, or has not received IFN-a in the past 6 months. Exclusion Criteria: * posi...

Countries:Turkey (Türkiye)
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Frequently asked questions about adefovir dipivoxil

What is adefovir dipivoxil used for?

Adefovir dipivoxil is an investigational small molecule being studied for the treatment of chronic hepatitis B. It is being developed by Roche Holding AG (ticker: RHHBY). The drug is currently in Phase 3 clinical development for this infectious disease indication.

Who makes adefovir dipivoxil?

Adefovir dipivoxil is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug as a treatment for chronic hepatitis B.

What phase is adefovir dipivoxil in?

Adefovir dipivoxil is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is being studied for chronic hepatitis B.

What clinical trials is adefovir dipivoxil in?

Adefovir dipivoxil has been studied in one completed Phase 3 trial, NCT00661076, known as the ADVANCE Study. This trial evaluated PEGASYS (peginterferon alfa-2a) plus adefovir dipivoxil in patients with HBe(-) chronic hepatitis B. The trial enrolled 10 participants in Turkey.

How does adefovir dipivoxil work?

Adefovir dipivoxil is a small molecule antiviral agent. It works by inhibiting the activity of viral DNA polymerase, an enzyme essential for hepatitis B virus replication. By blocking this enzyme, the drug interferes with the virus's ability to multiply in the body.