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Entecavir

Phase 3

Hepatitis B | Small molecule | Infectious Disease |Novartis AG|Last Updated: Mar 13, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

Entecavir · 1 trial · 2 indications

Phase 3 1
NCT00412529Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis BHepatitis B
COMPLETED44 Analytics
PHASE3COMPLETED
Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Mean Hepatitis B Virus (HBV) DNA Levels
Baseline (day 1) to Week 12 (day 85)

Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.

Secondary Endpoints

Change in Mean HBV DNA Level
Baseline (day 1) to Weeks 2, 4, 8
The Area Under the Curve (AUC) of HBV DNA Change.
From Baseline to Week 12
Change in Alanine Aminotransferase (ALT) Levels
From Baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TelbivudineEXPERIMENTAL -
EntecavirACTIVE_COMPARATOR -

Interventions

NameTypeDescription
EntecavirDRUGEntecavir 0.5 mg once daily for 12 weeks.
TelbivudineDRUGTelbivudine 600 mg once daily for 12 weeks.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B * Able to comply with study regimen and provide written informed consent Exclusion Criteria: * Pregnant or breastfeeding * Unwilling to use double barr...

Countries:South Korea
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Frequently asked questions about Entecavir

What is Entecavir used for?

Entecavir is used for the treatment of Hepatitis B, specifically chronic Hepatitis B. It is a small molecule being developed by Novartis AG. The drug is currently in Phase 3 clinical development for this indication.

How does Entecavir work?

Entecavir is a small molecule antiviral agent. It works by inhibiting the hepatitis B virus polymerase, thereby suppressing viral replication. This mechanism helps reduce the viral load in patients with chronic Hepatitis B infection.

Who makes Entecavir?

Entecavir is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical trials for Hepatitis B.

What phase is Entecavir in?

Entecavir is in Phase 3 clinical development. It is an investigational drug for the treatment of Hepatitis B and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is Entecavir in?

Entecavir has one completed Phase 3 clinical trial with the identifier NCT00412529. This trial was a viral kinetics study comparing telbivudine and entecavir in adults with chronic Hepatitis B. The study enrolled 44 participants and was conducted in South Korea.

Is Entecavir the same as telbivudine?

No, Entecavir is not the same as telbivudine. They are different antiviral drugs used for Hepatitis B. In a clinical trial, they were compared against each other to evaluate their viral kinetics in patients with chronic Hepatitis B.