Clinical trials: Hepatitis B Virus
Hepatitis A, Viral Hepatitis Vaccines
Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.
- Trial name
- NCT02112890
- Testing
- Data collection
- Where
- Mexico
- Volunteers
- 1,603 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Tetanus
Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age
The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine.
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria, Hepatitis B
- Trial name
- NCT00376779
- Testing
- Infanrix hexa Vaccine
- Where
- 6 sites in Finland
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis b
A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo
This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.
- Trial name
- NCT03642340
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
Chronic Hepatitis B
Long-term Study With Clevudine
A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.
- Trial name
- NCT00558818
- Testing
- Clevudine
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Bukwang Pharmaceutical
Exposure to Hepatitis B Virus
Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine
There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years.
- Trial name
- NCT01951677
- Testing
- HBsAg, PreS HBsAg, Advax-1(TM)
- Where
- Australia
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Vaxine Pty Ltd
Chronic Hepatitis B
A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients
This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up…
- Trial name
- NCT01266005
- Testing
- Clevudine, Entecavir
- Where
- South Korea
- Volunteers
- 75 people
- Sponsor
- Bukwang Pharmaceutical
Chronic Hepatitis B
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver…
- Trial name
- NCT00298363
- Testing
- Tenofovir disoproxil fumarate (tenofovir DF; TDF), Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), Entecavir (ETV)
- Where
- 38 sites in United States, Canada and 9 more
- Volunteers
- 112 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)
This is a prospective, multi-centre, randomized, double-blind, placebo-controlled, Phase 2a experimental study of oral FXR modulator EYP001a/placebo combined with NAs in virologically suppressed CHB patients to improve functional…
- Trial name
- NCT04465916
- Testing
- EYP001a, Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
- Where
- 18 sites in Australia, Hong Kong and 2 more
- Volunteers
- 26 people
- Sponsor
- Enyo Pharma
Hepatitis B
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB.
- Trial name
- TDF in CHB (NCT01300234)
- Testing
- Tenofovir disoproxil fumarate (TDF) tablets, Adefovir dipivoxil (ADV) tablets
- Where
- 20 sites in China
- Volunteers
- 512 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV).
- Trial name
- NCT00436163
- Testing
- Peginterferon alfa-2a
- Where
- 9 sites in Estonia, Latvia and 1 more
- Volunteers
- 39 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Hepatitis A
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
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 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis…
- Trial name
- NCT00289718
- Testing
- Twinrix™ adult
- Where
- Belgium
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive chronic hepatitis B (CHB) and low hepatitis B surface antigen (HBsAg) levels.
- Trial name
- NCT04684914
- Testing
- HepTcell
- Where
- 21 sites in United States, Canada and 3 more
- Volunteers
- 87 people
- Sponsor
- Altimmune, Inc.
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are…
- Trial name
- NCT02613871
- Testing
- LDV/SOF
- Where
- 8 sites in Taiwan
- Volunteers
- 111 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®)…
- Trial name
- NCT01667432
- Testing
- Peginterferon alfa-2a
- Where
- 9 sites in Bulgaria
- Volunteers
- 141 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet
The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.
- Trial name
- NCT02589457
- Testing
- CKD-390, Viread® tablet
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Hepatitis B
A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™
Each Sci-B-Vac™ lot to be released to the market is tested in comparison to a reference batch,which has to be tested in a human clinical trial. This study was conducted by SciVac Ltd.
- Trial name
- NCT04179786
- Testing
- Sci-B-Vac™
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Hepatitis B
Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns
The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their…
- Trial name
- NCT01349283
- Testing
- HepavaxGene (thiomersal free), Engerix B
- Where
- China
- Volunteers
- 1,738 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Chronic Hepatitis B
A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers
This is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect of HRS5091 on CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP and OATP1B1, using midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin as…
- Trial name
- NCT05273775
- Testing
- HRS5091 Tablets, Midazolam Maleate Tablets, Warfarin Sodium Tablets
- Where
- China
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Chronic Hepatitis B
A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.
- Trial name
- NCT07069569
- Testing
- AHB-137, Peg-IFN, Hepatitis B Vaccine
- Where
- 14 sites in China
- Volunteers
- 200 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Hepatitis B
A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide…
- Trial name
- B-Clear (NCT04449029)
- Testing
- GSK3228836, Nucleos(t)ide therapy
- Where
- 121 sites in United States, Argentina and 20 more
- Volunteers
- 457 people
- Sponsor
- GlaxoSmithKline