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

Clinical Trials

Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers

Phase 3

Recruiting

Conditions: Gastrointestinal Cancers

Interventions: Drug: Entecavir

First Posted Date: 2025-05-11

Last Posted Date: 2025-05-11

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 136

Registration Number: NCT06966232

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B

Phase 1

Active, not recruiting

Conditions: Chronic Hepatitis b

Interventions: Drug: TQA3605 tablets
Drug: Placebo
Drug: Entecavir dispersible tablets
Drug: Tenofovir disoproxil fumarate tablet
Drug: Tenofovir alafenamide fumarate tablet

First Posted Date: 2023-11-29

Last Posted Date: 2024-11-14

Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Target Recruit Count: 88

Registration Number: NCT06150014

Locations: 🇨🇳
The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
🇨🇳
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University, Chongqing, Chongqing, China
🇨🇳
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shannxi, China

Finite Versus Continuous Nucleos(t)Ide Analogues for Chronic Hepatitis B

Not Applicable

Active, not recruiting

Conditions: Chronic Hepatitis b

Interventions: Other: Nuc Discontinuation
Drug: Entecavir or Tenofovir

First Posted Date: 2023-03-31

Last Posted Date: 2023-03-31

Lead Sponsor: E-DA Hospital

Target Recruit Count: 360

Registration Number: NCT05793268

Locations: 🇨🇳
Taitung Mackay Memorial Hospital, Taitung, Taiwan
🇨🇳
Lotung Poh-Ai Hospital, Yilan, Taiwan
🇨🇳
Fu-Jen Catholic University Hospital, Taipei, Taiwan

and more 3 locations

Synbiotics Interventions for Managing Cirrhosis and Its Complications

Phase 4

Completed

Conditions: Cirrhosis, Liver
Metagonimiasis

Interventions: Drug: Entecavir 0.5 mg
Dietary Supplement: A 10-g packet of glucose oral solution and three capsules of starch
Drug: A 10-g packet of lactulose oral solution and three capsules of probiotics

First Posted Date: 2023-01-18

Last Posted Date: 2023-01-18

Lead Sponsor: First Affiliated Hospital of Zhejiang University

Target Recruit Count: 120

Registration Number: NCT05687409

Locations: 🇨🇳
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

Not Applicable

Recruiting

Conditions: Chronic Hepatitis B Virus Infection

Interventions: Drug: Entecavir
Drug: Ropeginterferon alfa-2b

First Posted Date: 2022-08-10

Last Posted Date: 2022-12-27

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 90

Registration Number: NCT05494528

Locations: 🇨🇳
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan
🇨🇳
China Medical University Hospital, Taichung, Taiwan
🇨🇳
National Taiwan University Hospital, Taipei, Taiwan

and more 2 locations

Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)

Phase 2

Recruiting

Conditions: CD20 Positive B-cell Lymphoma
Resolved Hepatitis B

Interventions: Drug: Entecavir

First Posted Date: 2022-07-12

Last Posted Date: 2024-05-07

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 84

Registration Number: NCT05453435

Locations: 🇨🇳
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, Guangzhou, State..., China

The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study

Not Applicable

Completed

Conditions: Antiviral Drugs

Interventions: Drug: Entecavir
Drug: tenofovir alafenamide

First Posted Date: 2022-07-12

Last Posted Date: 2022-07-12

Lead Sponsor: Xiangya Hospital of Central South University

Target Recruit Count: 272

Registration Number: NCT05453448

Locations: 🇨🇳
Wenting Peng, Changsha, China

Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Active, not recruiting

Conditions: Chronic Hepatitis B

Interventions: Drug: Entecavir
Drug: Tenofovir alafenamide

First Posted Date: 2022-06-21

Last Posted Date: 2023-02-08

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 1800

Registration Number: NCT05423834

Locations: 🇭🇰
Prince of Wales Hospital, Shatin, Hong Kong

A Single and Multiple Ascending Dose Study of JNJ-64457744

Phase 1

Terminated

Conditions: Hepatitis B, Chronic
Healthy

Interventions: Drug: JNJ-64457744
Drug: Placebo
Drug: Tenofovir Disoproxil Fumarate (TDF)
Drug: Tenofovir Alafenamide (TAF)
Drug: Entecavir (ETV)

First Posted Date: 2022-06-21

Last Posted Date: 2025-02-03

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 60

Registration Number: NCT05423106

Locations: 🇳🇿
New Zealand Clinical Research, Grafton, New Zealand

Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study

Phase 1

Completed

Conditions: Hepatitis B, Chronic

Interventions: Drug: Freethiadine tablets (part II)
Drug: entecavir tablets
Drug: Freethiadine tablets(part I)
Drug: Freethiadine placebo tablets

First Posted Date: 2022-05-25

Last Posted Date: 2023-04-12

Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Target Recruit Count: 128

Registration Number: NCT05391360

Locations: 🇨🇳
The First Hospital of Jilin University, Changchun, Jilin, China
🇨🇳
Southern Hospital of Southern Medical University, Guangzhou, Guangdong, China

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