Clinical trials: Hepatitis B Infections
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
Hepatitis B, Hepatitis C
Observational Study on Prevalence of Host and Viral Genotypes in Chronic Hepatitis B and Hepatitis C Patients in India
This study will define the substantial disease burden associated with viral hepatitis in India, and provide a foundation to understand the host and viral determinants of disease pathogenesis that may ultimately impact treatment…
- Trial name
- NCT01772121
- Where
- 19 sites in India
- Volunteers
- 1,000 people
- Sponsor
- Gilead Sciences
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, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT00614471
- Testing
- Entecavir, peginterferon alfa-2a [Pegasys]
- Where
- 8 sites in China, Hong Kong
- Volunteers
- 219 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in…
- Trial name
- NCT00697931
- Testing
- Recombinant MPL- adjuvanted hepatitis B vaccine, Engerix™-B
- Where
- Belgium
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old.
- Trial name
- NCT00511095
- Testing
- HEPLISAV
- Where
- 7 sites in United States
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Hepatitis B, Chronic Hepatitis B
Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers
This is an open-label, randomized, multi-part study to evaluate the relative oral bioavailability of a tablet formulation of AL-3778 (formerly NVR 3-778) administered under fasted and fed conditions (Parts 1 and 2) and the…
- Conditions
- Hepatitis B, Chronic Hepatitis B, Viral Hepatitis B
- Trial name
- NCT03032536
- Testing
- AL-3778, Entecavir, Tenofovir disoproxil fumarate
- Where
- 2 sites in New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Diphtheria, Hepatitis B
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks.
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT02853929
- Testing
- Infanrix hexa
- Where
- 29 sites in Australia, Canada and 4 more
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
- Trial name
- HBV (NCT02499562)
- Testing
- Hydronidone, Entecavir
- Where
- 2 sites in China
- Volunteers
- 168 people
- Sponsor
- Shanghai Genomics, Inc.