Clinical trials: Chronic Hepatitis B Infections
Chronic Hepatitis B
Hepatitis B Surface Antigen(HBsAg) Loss in Chronic Hepatitis B Patients With Low Viral Load
Rationale: Worldwide, approximately 400 million people are chronically infected with hepatitis B virus (HBV). Chronic HBV infection increases the risk of developing cirrhosis, hepatic decompensation and hepatocellular carcinoma…
- Trial name
- LVL (NCT00973219)
- Testing
- Peg-Interferon alfa 2a + Adefovir dipivoxil, Peg-Interferon alfa 2a + Tenofovir disoproxil fumarate
- Where
- Netherlands
- Volunteers
- 151 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Chronic Hepatitis B
Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a
Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver.
- Trial name
- DNA-EVAL (NCT00199732)
- Where
- 4 sites in France
- Volunteers
- 19 people
- Sponsor
- University Hospital, Limoges
Chronic Hepatitis B
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN…
- Trial name
- NCT01277601
- Testing
- TDF, Peg-IFN
- Where
- 171 sites in United States, Australia and 17 more
- Volunteers
- 751 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Safety and Tolerability of TG1050: A Dose-finding Study
Methodology: This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection.
- Trial name
- NCT02428400
- Testing
- TG1050
- Where
- 12 sites in Canada, France and 1 more
- Volunteers
- 48 people
- Sponsor
- Transgene
Hepatocellular Carcinoma (HCC)
HCC Risk Prediction Model Based on Multimodal Data in Chronic Hepatitis B
The investigators propose to construct and validate an early HCC risk prediction model in a multicenter retrospective cohort of hepatitis B-related fibrosis/cirrhosis patients, using multimodal data encompassing longitudinal…
- Trial name
- NCT07780357
- Testing
- No intervention (observational study)
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Beijing Friendship Hospital
Hepatocellular Carcinoma, Liver Cirrhosis
Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC)
This prospective multicenter observational study evaluates the performance of a structured hepatocellular carcinoma (HCC) surveillance program in patients at increased risk of developing liver cancer.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis B, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Trial name
- Screening HCC (NCT07764835)
- Volunteers
- 300 people
- Sponsor
- D'Or Institute for Research and Education
Hepatitis B, ESRD (End Stage Renal Disease)
Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis
People with kidney failure who are on dialysis have a weaker immune response to the hepatitis B vaccine than healthy people. Even after vaccination, many dialysis patients do not develop enough protection against hepatitis B…
- Conditions
- Hepatitis B, ESRD (End Stage Renal Disease), Kidney Failure, Chronic
- Trial name
- 3v4-HEP-DOSE (NCT07784452)
- Testing
- Recombinant Hepatitis B Vaccine - 3-Dose Schedule, Recombinant Hepatitis B Vaccine - 4-Dose Schedule
- Where
- Pakistan
- Volunteers
- 104 people
- Sponsor
- Jinnah Hospital
Sustained Virologic Response, Hepatitis B, Chronic
Real World Study About Anti-viral Regimen Adjustment on Achieving Complete Response in CHB Patients
In the treatment of chronic hepatitis B (CHB), viral suppression is closely related to disease progression, and the lower the viral load, the lower the risk of progression to cirrhosis and hepatocellular carcinoma (HCC).
- Trial name
- REACH (NCT04724785)
- Testing
- only monitoring, monitoring and regimen change if necessary, regimen change
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
Chronic Hepatitis B
Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after…
- Trial name
- NCT02589652
- Testing
- Pegylated interferon alfa-2a, Pegylated interferon alfa-2a plus Entecavir, Entecavir
- Where
- 17 sites in China
- Volunteers
- 294 people
- Sponsor
- Huashan Hospital
Hepatitis B, Chronic
EFFORT Extension Study
The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
- Trial name
- EFFORT-Ex (NCT01529255)
- Testing
- telbivudine (ROADMAP), Telbivudine (Standard of Care)
- Where
- 24 sites in China
- Volunteers
- 576 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Hepatitis B, Chronic
A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of…
- Trial name
- NCT06452693
- Testing
- Nucleotide drugs Control group
- Where
- 22 sites in China
- Volunteers
- 162 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hepatitis B
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver
- Trial name
- NCT03604016
- Testing
- Besifovir dipivoxil, L-carnitine, Tenofovir Alafenamide
- Volunteers
- 76 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
Hepatitis B, Chronic
Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already…
- Trial name
- NCT02726789
- Testing
- REP 2139-Ca, pegylated interferon, entecavir
- Volunteers
- 5 people
- Sponsor
- Replicor Inc.
Chronic Hepatitis B
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir.
- Trial name
- NCT06990776
- Testing
- TQA3605 Tablets, Entecavir dispersible tablets
- Where
- 29 sites in China
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
Hepatitis B, Chronic
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC).
- Trial name
- NCT02224456
- Testing
- Tenofovir disoproxil fumarate
- Where
- 19 sites in China
- Volunteers
- 197 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B e Antigen Positive, Chronic Hepatitis B e Antigen Negative
Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B
Background: Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and cancer of the liver. There is no cure for the infection, but several drugs have been approved to treat it.
- Trial name
- NCT01581554
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis B, Chronic
ANRS HB07 IP-Cure-B Proof of Concept (PoC) Clinical Trial. Educating the Liver Immune Environment Through TLR8 Stimulation Followed by NUC Discontinuation
The ANRS HB07 IP-cure-B study is a proof of concept Phase II clinical trial in HBeAg negative virally suppressed non-cirrhotic CHB patients.
- Trial name
- IP-CURE-B (NCT05045261)
- Testing
- administration of SLGN in arm C, Discontinuation of NUC treatment in arms B and C
- Where
- 8 sites in France, Germany and 2 more
- Volunteers
- 100 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Chronic Hepatitis B
Pegasys Plus Entecavir Versus Entecavir Alone for Hepatitis Be Antigen-Positive Chronic Hepatitis B
Although the best treatment choice for chronic hepatitis B is not clarified yet, certain therapeutic concepts could be derived from the experience of treating patients with chronic hepatitis C or human immunodeficiency virus…
- Trial name
- NCT00597259
- Testing
- Pegasys plus Entecavir, Entecavir
- Where
- Taiwan
- Volunteers
- 294 people
- Sponsor
- National Taiwan University Hospital
Hepatitis B
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration…
- Trial name
- NCT00376259
- Testing
- telbivudine, adefovir dipivoxil
- Where
- 6 sites in United States, Hong Kong and 3 more
- Volunteers
- 43 people
- Sponsor
- Novartis
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