Clinical trials: Hepatitis B Infections
Hepatitis B
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype
- Trial name
- NCT00697749
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™
The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™.
- Trial name
- NCT00445185
- Testing
- Henogen HB vaccine, Fendrix vaccine
- Where
- 23 sites in Belgium, Czechia and 1 more
- Volunteers
- 102 people
- Sponsor
- Henogen
Hepatitis B, Chronic
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients
This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose, adaptive parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of…
- Trial name
- NCT02604355
- Testing
- RO7020322
- Where
- 4 sites in Hong Kong, New Zealand and 1 more
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Diphtheria
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix…
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis
- Trial name
- NCT01457508
- Testing
- DTPa-HBV-IPV/Hib (Infanrix hexa™), DTPa-HBV-IPV (Infanrix penta™), Hib (Hiberix™)
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Chronic Hepatitis, Hepatitis B
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.
- Trial name
- QUASH2 (NCT00496158)
- Testing
- Clevudine, Adefovir
- Where
- 119 sites in United States, Argentina and 9 more
- Sponsor
- Pharmasset
Infections, Papillomavirus, Papillomavirus Vaccines
Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine…
- Trial name
- NCT00637195
- Testing
- Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™), Engerix™
- Where
- 2 sites in Belgium
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults
This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta co-administered with Imovax Polio in healthy adults.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT03208101
- Testing
- DTP-HepB-IPV-Hib vaccine, DTP-HepB-Hib vaccine & IPV
- Where
- South Korea
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- LG Chem
Chronic Hepatitis B
A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients
The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years， which is compared hepalatide in combination with Pegylated Interferon + TAF with…
- Trial name
- NCT05244057
- Testing
- Hepalatide, Tenofovir Alafenamide Tablets, Pegylated Interferon alfa 2a
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Shanghai HEP Pharmaceutical Co., Ltd.
Hepatitis B
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.
- Trial name
- NCT00429481
- Testing
- Rotarix
- Volunteers
- 2,464 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Liver Transplantation
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection.
- Trial name
- NCT00228592
- Testing
- HepeX-B, Hepatitis B Immune Globulin (HBIg)
- Where
- 20 sites in United States, France and 5 more
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Chronic HBV Infection
A Study to Evaluate the Safety, Tolerability of HH-003 Injection in Participants With Chronic Hepatitis B Virus Infection
This is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose phase Ib study of HH-003 injection, which is a monoclonal antibody targeting Hepatitis B virus.
- Trial name
- NCT05542979
- Testing
- HH-003 injection
- Where
- 11 sites in China
- Volunteers
- 68 people
- Sponsor
- Huahui Health
Hepatitis B
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
- Trial name
- NCT00291941
- Testing
- Henogen HBV vaccine, FENDRIX
- Where
- 24 sites in Belgium, Czechia and 1 more
- Volunteers
- 300 people
- Sponsor
- Henogen
Chronic Hepatitis B
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.
- Trial name
- NCT01264094
- Testing
- Clevudine
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Bukwang Pharmaceutical
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
Hepatitis B
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.
- Trial name
- NCT01627340
- Testing
- Engerix™-B vaccine
- Where
- 22 sites in United States, Australia and 2 more
- Volunteers
- 667 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation
The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus…
- Trial name
- NCT00895713
- Testing
- intramuscular hepatitis B virus immune globulin
- Where
- 2 sites in Italy
- Volunteers
- 18 people
- Sponsor
- Instituto Grifols, S.A.
Chronic Hepatitis b
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection.
- Trial name
- HBV003 (NCT03038802)
- Testing
- Therapeutic hepatitis B vaccine, Commercial Hepatitis B vaccine
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Vaxine Pty Ltd
Hepatitis B, Chronic
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B.
- Trial name
- NCT00962975
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 6 sites in United States, New Zealand and 2 more
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.
- Trial name
- NCT02588937
- Testing
- EntecaBell ODT. 0.5mg, Baraclude Tab. 0.5mg
- Where
- 9 sites in South Korea
- Volunteers
- 76 people
- Sponsor
- Chong Kun Dang Pharmaceutical