Clinical trials: Chronic Hepatitis, B Virus
Hepatitis B
Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.
To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.
- Trial name
- NCT00158717
- Testing
- Hepsera
- Volunteers
- 107 people
- Sponsor
- Gilead Sciences
Hepatitis B, Healthy
First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication.
- Trial name
- NCT04297917
- Testing
- ChAdOx1-HBV
- Where
- 4 sites in United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Barinthus Biotherapeutics
Hepatitis B, Chronic
Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection
This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy
- Trial name
- MARCH (NCT04856085)
- Testing
- VIR-2218, VIR-3434, PEG-IFNα
- Where
- 37 sites in United States, Canada and 10 more
- Volunteers
- 244 people
- Sponsor
- Vir Biotechnology, Inc.
Hepatitis B
Follow-up of HBsAg Inactive Carriers Study
The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ".
- Trial name
- PIBAC (NCT02247752)
- Testing
- inactive carrier
- Where
- 32 sites in France
- Volunteers
- 619 people
- Sponsor
- Centre Hospitalier Régional d'Orléans
Chronic Hepatitis B Virus (Hbv)
Optimizing HBV Care Cascade Among Foreign-Born in the United States (FOCUS-HBV Study)
Background: People who were born outside of the country are the largest group of adults infected with chronic hepatitis B virus (HBV) in the US. HBV affects the liver.
- Trial name
- NCT05621304
- Where
- 2 sites in United States
- Volunteers
- 274 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis B, Chronic
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine
The purpose of this study is to evaluate the efficacy and safety of the investigational medicinal product CVI-HBV-002.
- Trial name
- NCT04289987
- Testing
- CVI-HBV-002
- Where
- 9 sites in South Korea
- Volunteers
- 134 people
- Sponsor
- Aribio Lab Co., Ltd.
Chronic Hepatitis B
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Background: The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.
- Trial name
- NCT01817725
- Testing
- HBV vaccine (Engerix B)
- Where
- Taiwan
- Volunteers
- 20 people
- Sponsor
- Chang Gung Memorial Hospital
Liver Disease Chronic, Hepatitis B Virus
Efficacy of HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease.
Background: Cirrhotic patients have an increased risk of infections. In these patients is important to prevent hepatitis B virus (HBV) infection, as it may cause a deterioration of liver function.
- Trial name
- NCT03459521
- Testing
- Fendrix or HBVAXPRO 40
- Where
- Spain
- Volunteers
- 125 people
- Sponsor
- Corporacion Parc Tauli
Immunologic Tests
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
- Trial name
- NCT01098006
- Testing
- Blood withdrawal
- Where
- 2 sites in Belgium
- Volunteers
- 99 people
- Sponsor
- GlaxoSmithKline
Chronic HBV Infection, Drug Withdrawal
Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage
As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA) transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host interactionsduring chronic hepatitis B viral…
- Trial name
- NCT03909191
- Testing
- serum HBV RNA
- Volunteers
- 454 people
- Sponsor
- Changhai Hospital
Chronic Hepatitis B, Pregnancy Complications
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored.
- Conditions
- Chronic Hepatitis B, Pregnancy Complications, High Viral Load, Elevated Alanine Aminotransferase Levels
- Trial name
- NCT01337791
- Testing
- Telbivudine treatment
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Southeast University, China
Chronic Hepatitis B
PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients
This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.
- Trial name
- PAS (NCT01373684)
- Testing
- Peginterferon alfa-2a, Nucleos(t)ide analogue
- Where
- 8 sites in Canada, Netherlands
- Volunteers
- 90 people
- Sponsor
- Foundation for Liver Research
Chronic Hepatitis B Infection, High Viral Load
Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate.
- Trial name
- NCT04135235
- Testing
- TAF, TDF
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Beijing Ditan Hospital
Chronic Hepatitis B
Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine
This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.
- Trial name
- NCT00513968
- Testing
- a mixed plasmid DNA (HB-110), Adefovir
- Where
- South Korea
- Volunteers
- 27 people
- Sponsor
- Genexine, Inc.
Chronic Hepatitis B
A Study in Japan of the Safety and Antiviral Activity With Chronic Hepatitis B Infection
The objectives of this study are to demonstrate that entecavir has antiviral activity with undetectable at Week 48, and to assess the safety and the pharmacokinetic in Japanese patients given entecavir at each dose of 0.1 and 0.5…
- Trial name
- NCT01020565
- Testing
- Entecavir
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
HBsAg Related Response Guided Therapy
Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up) Secondary objective : The changes of…
- Trial name
- S-RGT (NCT01456312)
- Testing
- Peginterferon alfa-2a, Entecavir
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Gangnam Severance Hospital
Chronic Hepatitis B
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only…
- Trial name
- NCT04423393
- Testing
- VIR-3434
- Where
- 24 sites in Germany, Hong Kong and 5 more
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Chronic Hepatitis B, HBV (Hepatitis B Virus)
Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients
This study is an open-label, 2-Part (Single Ascending Dose [Part 1] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB).
- Trial name
- NCT06661148
- Testing
- EPI-003
- Where
- 4 sites in Australia, China and 1 more
- Volunteers
- 36 people
- Sponsor
- Epigenic Therapeutics, Inc
Chronic Hepatitis B
Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B
According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide.
- Trial name
- NCT02263755
- Volunteers
- 476 people
- Sponsor
- Yonsei University
Hepatitis B, Chronic
An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys
This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated.
- Trial name
- NCT01011738
- Where
- 249 sites in Austria, Bahrain and 25 more
- Volunteers
- 1,842 people
- Sponsor
- Hoffmann-La Roche
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