Entecavir

Generic Name: Entecavir

Brand Names: Baraclude, Entecavir Viatris (previously Entecavir Mylan), Entecavir Accord

Drug Type: Small Molecule

Chemical Formula: C_₁₂H_₁₅N_₅O_₃

CAS Number: 142217-69-4

Unique Ingredient Identifier: NNU2O4609D

Background: Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. It is marketed under the trade name Baraclude (BMS).

Entecavir is a guanine analogue that inhibits all three steps in the viral replication process, and the manufacturer claims that it is more efficacious than previous agents used to treat hepatitis B (lamivudine and adefovir). It was approved by the U.S. Food and Drug Administration (FDA) in March 2005.

Indication: For the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Associated Conditions: Chronic Hepatitis B Infection

Associated Therapies: -

Clinical Trials

Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir

Phase 4

Conditions: Chronic Hepatitis B

Interventions: Drug: Telbivudine
Drug: Entecavir
Drug: Tenofovir

First Posted Date: 2012-05-01

Last Posted Date: 2012-05-02

Lead Sponsor: Pusan National University Yangsan Hospital

Target Recruit Count: 104

Registration Number: NCT01588912

Locations: 🇰🇷
Byung Chul Yoon, Busan, Korea, Republic of
🇰🇷
Eun Uk Jung, Busan, Korea, Republic of
🇰🇷
Hyun Young Woo, Busan, Korea, Republic of

and more 7 locations

Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine

Phase 3

Completed

Conditions: Hepatitis B
Malignancy

Interventions: Drug: Lamivudine
Drug: Entecavir

First Posted Date: 2012-04-18

Last Posted Date: 2017-06-29

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 180

Registration Number: NCT01580202

Locations: 🇰🇷
National Cancer Center, Korea, Goyang, Gyeonggi, Korea, Republic of
🇰🇷
Seoul National University Bundang Hospital, Seongnam, Gyeonggi, Korea, Republic of
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

and more 2 locations

HBsAg Related Response Guided Therapy

Phase 4

Conditions: Hepatitis B, Chronic

Interventions: Drug: Peginterferon alfa-2a
Drug: Entecavir

First Posted Date: 2011-10-20

Last Posted Date: 2012-10-31

Lead Sponsor: Gangnam Severance Hospital

Target Recruit Count: 200

Registration Number: NCT01456312

Locations: 🇰🇷
Shinchon Severance Hospital, Seoul, Korea, Republic of

Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials

Phase 2

Completed

Conditions: Hepatitis B Virus
HBV

Interventions: Drug: Entecavir
Drug: Lamivudine

First Posted Date: 2011-09-22

Last Posted Date: 2012-08-23

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 1053

Registration Number: NCT01438424

Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Phase 4

Conditions: Hepatitis B

Interventions: Drug: Entecavir, Adefovir
Drug: Entecavir

First Posted Date: 2011-04-26

Last Posted Date: 2013-10-30

Lead Sponsor: Nanfang Hospital, Southern Medical University

Target Recruit Count: 360

Registration Number: NCT01341743

Locations: 🇨🇳
Shanghai Ruijin Hospital, ShangHai, Shanghai, China
🇨🇳
First Hospital .Jilin Unniversity, ChangChun, Jilin, China
🇨🇳
Changhai Hospital affiliated to Second Military Medical University, ShangHai, Shanghai, China

and more 13 locations

Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients

Phase 2

Completed

Conditions: Chronic Hepatitis B

Interventions: Biological: Therapeutic HBV vaccine
Drug: entecavir
Other: placebo

First Posted Date: 2011-03-31

Last Posted Date: 2019-06-26

Lead Sponsor: Chongqing Jiachen Biotechnology Ltd.

Target Recruit Count: 378

Registration Number: NCT01326546

Locations: 🇨🇳
The First Affiliated of Anhui Medical University, Hefei, Anhui, China
🇨🇳
81th Hospital of PLA, NanJing, Jiangsu, China
🇨🇳
Jiangsu Province Hospital, NanJing, Jiangsu, China

and more 12 locations