Clinical trials: Nucleos(t)Ide Analogues Treatment
Chronic Hepatitis b
Effect of Serum Vitamin D Level on the Efficacy of Peg-interferon Treatment in CHB
In recent years, vitamin D (VD) has received much attention in the fields of host immune regulation, inflammation, fibrosis, cell proliferation and differentiation and tumor. VD works by binding to the vitamin D receptor (VDR).
- Trial name
- NCT05753280
- Testing
- Vitamin D
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Chronic Hepatitis B
Sustained Off-treatment Response After HBeAg Loss in Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues
This is a prospective randomized, open-label, phase IV clinical trial to learn the effects, good and/or bad, of discontinuing or continuing nucleos(t)ide analogue (NA) treatment for 72 weeks in participants with chronic hepatitis…
- Trial name
- Stop (NCT01911156)
- Testing
- Continue NA treatment, Discontinue NA Treatment
- Where
- 2 sites in Canada
- Volunteers
- 66 people
- Sponsor
- University Health Network, Toronto
Chronic Hepatitis B
Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy
Patients with Chronic Hepatitis B on long term oral antiviral therapy have to continue treatment indefinitely unless they achieve HBeAg seroconversion or HBsAg seroclearance, when therapy can be stopped.
- Trial name
- SWAP (NCT01928511)
- Testing
- peg-interferon alpha 2b, 1.5mcg/kg s/c given weekly, Nucleos(t)ide analogue therapy
- Where
- 4 sites in Singapore
- Volunteers
- 254 people
- Sponsor
- Seng Gee Lim
Hepatocellular Carcinoma (HCC), Chronic Hepatitis B
Post-Radical Treatment Antiviral Strategies in HBV-Related Liver Cancer: Impact on Tumor Prognosis
The goal of this clinical trial is to learn if peginterferon alfa-2b can reduce the recurrence of HBV-related liver cancer in patients who have undergone radical treatment.
- Trial name
- PRTRAS 001 (NCT07120750)
- Testing
- Intervention for Group 1, Intervention for Group 2
- Volunteers
- 332 people
- Sponsor
- Shenzhen Third People's Hospital
Chronic Hepatitis b
Finite Versus Continuous Nucleos(t)Ide Analogues for Chronic Hepatitis B
BACKGROUND: Finite nucleos(t)ide analogue (Nuc) therapy was proposed as an alternative strategy in the management of chronic hepatitis B (CHB) but there remained not data from randomized controlled trials to clarify safety and…
- Trial name
- NCT05793268
- Testing
- Nuc Discontinuation, Entecavir or Tenofovir
- Where
- 6 sites in Taiwan
- Volunteers
- 360 people
- Sponsor
- E-DA Hospital
HBV, Chronic Hepatitis b
A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
This is a multicenter, prospective, real-world study. The study plans to include a total of 2000 patients who meet the inclusion and exclusion criteria, consisting of 1600 treatment-naive patients and 400 treatment-experienced…
- Trial name
- NCT06926647
- Testing
- Nucleos(t)ide Analogues, Interferon alfa, NAs combined with IFNα
- Where
- 85 sites in China
- Volunteers
- 2,000 people
- Sponsor
- Beijing 302 Hospital
Chronic Hepatitis B
Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response
This is a multicenter, randomized, double-blind, placebo-controlled Phase III study with an open-label extension. The purpose is to evaluate efficacy and safety in adult patients with chronic hepatitis B virus infection who have…
- Trial name
- NCT07797231
- Testing
- TQA3605 tablets, Entecavir dispersible tablets, Tenofovir Disoproxil Fumarate Tablets
- Where
- 77 sites in China
- Volunteers
- 930 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chronic Hepatitis B
Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy
Background and aims: Nucleos(t)ide analogues may suppress HBV DNA to undetectable level, but only about 30-40% remain sustained response 1-3 years after discontinued therapy.
- Trial name
- NCT02505009
- Testing
- Engerix-B, Tenofovir, Entecavir
- Where
- Taiwan
- Volunteers
- 116 people
- Sponsor
- Chang Gung Memorial Hospital
Chronic Hepatitis B
Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHB
Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients.
- Trial name
- PEGON (NCT01532843)
- Testing
- PegIFN alfa-2b
- Where
- 4 sites in China, Netherlands
- Volunteers
- 82 people
- Sponsor
- Foundation for Liver Research
Chronic Hepatitis B
Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
- Trial name
- NCT07246889
- Testing
- AHB-137, NA therapy
- Where
- 28 sites in China
- Volunteers
- 577 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Chronic Hepatitis B
A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
This study is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.
- Trial name
- NCT06993480
- Testing
- AHB-137
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Chronic Hepatitis B (HBeAg-negative)
HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients
Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide…
- Trial name
- NCT02743182
- Testing
- Pegylated interferon alfa-2a
- Volunteers
- 119 people
- Sponsor
- José Antonio Carrion
Chronic Hepatitis b, Hepatitis B Reactivation
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
We will conduct a phase 4, multicenter, open-label trial at 8 academic centers in Taiwan. Chronic hepatitis B patients receiving oral antiviral therapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF]) for at least 1 year…
- Trial name
- CHANGE (NCT04496882)
- Testing
- Vemlidy
- Where
- 8 sites in Taiwan
- Volunteers
- 260 people
- Sponsor
- National Taiwan University Hospital
Chronic Hepatitis b
Biomarkers Guided Stopping NAs Treatment
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already…
- Trial name
- NCT04519359
- Testing
- Stop NAs therapy
- Where
- 5 sites in China
- Volunteers
- 195 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Chronic HBV Infection
A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia
This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia.
- Trial name
- NCT05734807
- Testing
- Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs), HH-003 and NrtIs, HH-003, NrtIs and PEG-IFN-α
- Where
- 8 sites in China
- Volunteers
- 74 people
- Sponsor
- Huahui Health
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
Metabolic Dysfunction-Associated Steatotic Liver Disease, Chronic Hepatitis B
Clinical Efficacy of Pegylated Interferon Alpha-2b Combined With Nucleos(t)Ide Analogues in the Treatment of Chronic Hepatitis B Patients
Background Chronic hepatitis B (CHB) is a global health issue that affects a large number of patients. There is currently controversy regarding the treatment strategies for CHB patients with metabolic-associated steatoliver…
- Trial name
- NCT07071636
- Testing
- Peg-IFN α-2b combined with NAs
- Volunteers
- 830 people
- Sponsor
- Shenzhen Third People's Hospital
Hepatitis B, Virus Diseases
The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure
HBV-related acute-on-chronic liver failure (ACLF) is a clinical syndrome defined as acute hepatic insult with diagnosed or undiagnosed chronic liver disease.
- Conditions
- Hepatitis B, Virus Diseases, Liver Failure
- Trial name
- NCT03640728
- Testing
- Tenofovir Alafenamide, Entecavir, Tenofovir disoproxil fumarate
- Where
- 11 sites in China
- Volunteers
- 200 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
To Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues in Nucleos(t)Ide-treated Patients With Chronic Hepatitis B
Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues on the Hepatitis B Surface Antigen of Virally Suppressed Subjects With Chronic Hepatitis B
In the globe, about 33% (2 billion) of population has ever been infected with hepatitis B virus (HBV), and about 5% (350-400 million) were chronical HBV infection.
- Trial name
- NCT05256823
- Testing
- Celecoxib, nucleos(t)ide analogue
- Where
- 4 sites in China
- Volunteers
- 47 people
- Sponsor
- Lai Wei
Hepatitis B, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B…
- Trial name
- NCT01706575
- Testing
- Pegylated Interferon (Peginterferon) Alfa-2a, Nucleos(t)ide Analogues (NA)
- Where
- 27 sites in Italy
- Volunteers
- 76 people
- Sponsor
- Hoffmann-La Roche