Clinical trials: Entecavir for Chronic Hepatitis B Patients
Hepatitis B
Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss
For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate.
- Trial name
- NCT01599130
- Testing
- Entecavir, Peginterferon alfa-2a
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sun Yat-sen University
Hepatitis B, Chronic
Antiviral Therapy in Hepatitis B Virus (HBV)-Related Advanced Liver Disease Patients
This is a randomized, open label, phase IV, multicenter study for efficacy and safety of lamivudine versus entecarvir therapy in HBV-related advanced liver disease patients with high viral load and normal or slightly elevated…
- Trial name
- NCT00823550
- Testing
- Entecavir, Lamivudine
- Where
- South Korea
- Volunteers
- 462 people
- Sponsor
- Yonsei University
Entecavir for Chronic Hepatitis B Patients
Entecavir for Chronic Hepatitis B
The primary aim of this study is to asses the efficacy (both virological and clinical) and safety of ETV in both NA-naïve and NA-experienced chronic hepatitis B patients, and to explore baseline factors associated with virologic…
- Trial name
- NCT01323452
- Testing
- Entecavir
- Where
- Netherlands
- Volunteers
- 418 people
- Sponsor
- Foundation for Liver Research
HBeAg-Positive Chronic Hepatitis B
Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B.
- Trial name
- NCT01913431
- Testing
- Baracle Tab.®, Baraclude Tab.®
- Where
- South Korea
- Volunteers
- 118 people
- Sponsor
- Dong-A ST Co., Ltd.
Chronic Hepatitis B
Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B
Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science…
- Trial name
- NCT04069858
- Testing
- Switching to Generic Entecavir (Baracle®)
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Korea University
Hepatitis B, Chronic
A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB
This is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with…
- Trial name
- NCT05484466
- Testing
- ZM-H1505R, Baraclude
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.
Chronic Hepatitis B
Adding Adefovir Dipivoxil Versus Switching to Entecavir in Patients With Lamivudine-resistant Chronic Hepatitis B
Antiviral resistance mutations limit the efficacy of therapy for chronic hepatitis B. At year 2, resistance to adefovir may occur as high as 25% in patients with history of lamivudine resistance.
- Trial name
- NCT00531167
- Testing
- combination of lamivudine+adefovir vs entecavir
- Where
- 2 sites in South Korea
- Volunteers
- 219 people
- Sponsor
- Korea University
Chronic Hepatitis
Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT
Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication, histology improvement as well as low rate of emergence of resistant mutants.
- Trial name
- NCT01833611
- Testing
- Entecavir
- Where
- 4 sites in Taiwan
- Volunteers
- 130 people
- Sponsor
- National Cheng-Kung University Hospital
Chronic Hepatitis B
Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection.
- Trial name
- NCT00388674
- Testing
- entecavir, Other anti-HBV medication
- Where
- 290 sites in United States, Argentina and 22 more
- Volunteers
- 12,522 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
Adefovir and Lamivudine for Entecavir Resistance (ALTER Study)
Entecavir has been one of the option for treatment of lamivudine resistant chronic hepatitis B (CHB). In case of entecavir resistance, adefovir could be used. However, sequential monotherapy may result in multidrug resistance.
- Trial name
- ALTER (NCT01546116)
- Testing
- ADEFOVIR, LAMIVUDINE
- Where
- 9 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Korea University
Chronic Hepatitis B, Inadequate Response
Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy
- Conditions
- Chronic Hepatitis B, Inadequate Response, Nucleos(t)Ide Analogues Treatment
- Trial name
- Dragon-Ex (NCT01829685)
- Testing
- Entecavir, Adefovir
- Where
- 16 sites in China
- Volunteers
- 360 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Chronic Hepatitis B
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
- Trial name
- NCT01026610
- Testing
- LB80380 90 mg, LB80380 150 mg, entecavir 0.5 mg
- Where
- 10 sites in China, South Korea
- Volunteers
- 115 people
- Sponsor
- LG Life Sciences
Chronic Hepatitis B
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)
- Trial name
- NCT03577171
- Testing
- ABI-H0731, SOC ETV
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 25 people
- Sponsor
- Assembly Biosciences
Hepatitis B
A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials
The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.
- Trial name
- NCT01337479
- Volunteers
- 1,097 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis b, Efficacy, Self
Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now.
- Trial name
- NCT03733652
- Testing
- Interferon Alfa 2a
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Hepatitis B
Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
- Trial name
- NCT01341743
- Testing
- Entecavir, Entecavir, Adefovir
- Where
- 16 sites in China
- Volunteers
- 360 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Chronic Hepatitis B
Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B
Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and five nucleons(t)ide analogues.
- Trial name
- NCT01906580
- Testing
- Peg-IFNα-2a, Entecavir
- Where
- China
- Volunteers
- 105 people
- Sponsor
- Beijing 302 Hospital
Hepatitis B, Chronic, Hepatocellular Carcinoma
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
The current first-line treatment for HBV is long-term oral antiviral drugs to inhibit HBV DNA replication. First-line antiviral drugs recommended by the Chinese 2015 Hepatitis B Guidelines include ETV and TDF.
- Conditions
- Hepatitis B, Chronic, Hepatocellular Carcinoma, Compensated Cirrhosis
- Trial name
- NCT04160897
- Testing
- Entecavir, Tenofovir Disoproxil
- Where
- China
- Volunteers
- 4,000 people
- Sponsor
- Qing XIe
Hepatitis B
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2…
- Trial name
- NCT03426618
- Testing
- Non-interventional
- Where
- South Korea
- Volunteers
- 1 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B, Hepatocellular Carcinoma
Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in turn leads to deterioration of liver reserve.
- Trial name
- NCT01270178
- Testing
- Entecavir
- Where
- Taiwan
- Volunteers
- 420 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan