Clinical trials: Hepatitis B Virus
Chronic Hepatitis B
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in…
- Trial name
- NCT00507689
- Testing
- FTC/TDF, Hepatitis B Immunoglobulin (HBIg)
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Hepatitis B
Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
The aim of this Observer-blind study is to compare different Adjuvant Systems with the same, well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B (Engerix-BTM and FendrixTM), in order to better…
- Trial name
- NCT00805389
- Testing
- Engerix-B™, Fendrix™, GSK Biologicals' Hepatitis B vaccines (GSK223192A)
- Where
- 14 sites in Belgium, Germany
- Volunteers
- 713 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis
Twinrix Pregnancy Registry
The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information…
- Trial name
- NCT03619590
- Testing
- Data Collection
- Volunteers
- 245 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01086085
- Testing
- Adefovir, peginterferon alfa-2a [PEGASYS]
- Where
- 11 sites in China
- Volunteers
- 265 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients
A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.
- Trial name
- NCT04133259
- Testing
- Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody, Nucleoside/nucleotide analogues
- Where
- 3 sites in Taiwan
- Volunteers
- 44 people
- Sponsor
- Henlix, Inc
Hepatitis B, Hepatitis A
Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis…
- Trial name
- NCT00289770
- Testing
- Twinrix™
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B Virus Infection
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV).
- Trial name
- NCT07389044
- Testing
- IB-001, Peginterferon Alfa-2A
- Where
- 5 sites in Hong Kong, Moldova and 2 more
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- IntegerBio
Hepatitis B, Hepatitis A
Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.
- Trial name
- NCT02135666
- Testing
- Blood sampling
- Where
- Czechia
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen [HBsAg] and Hepatitis B core antigen [HBcAg]) and…
- Trial name
- NCT02431312
- Testing
- INO-1800, INO-9112, Nucleos(t)ide Analogue Treatment
- Where
- 22 sites in United States, Australia and 6 more
- Volunteers
- 90 people
- Sponsor
- Inovio Pharmaceuticals
Chronic Hepatitis B
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral…
- Trial name
- NCT03109730
- Testing
- ABI-H0731, Entecavir, Tenofovir Disoproxil Fumarate
- Where
- 14 sites in Australia, Hong Kong and 3 more
- Volunteers
- 38 people
- Sponsor
- Assembly Biosciences
Chronic Hepatitis B
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.
- Trial name
- NCT04454567
- Testing
- ABI-H0731, NrtI
- Where
- 12 sites in United States, Hong Kong and 1 more
- Volunteers
- 2 people
- Sponsor
- Assembly Biosciences
Hepatitis B
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course…
- Trial name
- NCT00880477
- Testing
- DTPa-HBV-IPV/Hib vaccine, DTPa-IPV/Hib vaccine, EngerixTM-B
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs).
- Trial name
- NCT02195518
- Testing
- Tenofovir disoproxil fumarate
- Where
- 12 sites in China
- Volunteers
- 213 people
- Sponsor
- GlaxoSmithKline
End Stage Renal Disease
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on…
- Trial name
- NCT01195246
- Testing
- HEPLISAV, Engerix-B, Fendrix
- Where
- 19 sites in Germany
- Volunteers
- 155 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Hepatitis B
Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF arm) compared to participants who continue TDF…
- Trial name
- FINITE CHB (NCT01320943)
- Testing
- TDF, Stop TDF
- Where
- 13 sites in Germany
- Volunteers
- 43 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B Virus Infection
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT05970289
- Testing
- PEG-IFNα, BRII-835
- Where
- 28 sites in Australia, China and 3 more
- Volunteers
- 86 people
- Sponsor
- Brii Biosciences Limited
HBV
Access HBV Assays - European Union (EU) Clinical Trial Protocol -
The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.
- Trial name
- NCT04904835
- Testing
- Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
- Where
- 5 sites in France
- Volunteers
- 21,210 people
- Sponsor
- Beckman Coulter, Inc.
Hepatitis B
Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period
- Trial name
- NCT00362505
- Testing
- Clevudine
- Where
- 32 sites in South Korea
- Sponsor
- Bukwang Pharmaceutical