GlaxoSmithKline: Hepatitis B trials

The registry lists 144 Hepatitis B studies with GlaxoSmithKline as lead sponsor. 2 are open to participants now and 69 have results posted.

Phase 1 11Phase 2 36Phase 3 56Phase 4 36No phase 7(a study in two phases counts in both)

Studies

Page 1 of 2. Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study ParticipantsNot yet recruitingNCT07908459Phase 4
• A Study to Compare Blood Levels of Bepirovirsen and Safety Using Different Methods of Injecting in Healthy Adult ParticipantsNot yet recruitingNCT07905157Phase 1
• Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy VolunteersCompletedNCT06422767Phase 1Results posted
• A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult ParticipantsCompletedNCT06058390Phase 1Results posted
• A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 YearsCompletedNCT05561673Phase 1Results posted
• Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B InfectionTerminatedNCT05330455Phase 1/2Results posted
• Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)CompletedNCT04676724Phase 2Results posted
• A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis BCompletedNCT04544956Phase 2Results posted
• A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and ToddlersCompletedNCT04535037Phase 4Results posted
• A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)CompletedNCT04449029Phase 2Results posted
• Twinrix Pregnancy RegistryCompletedNCT03619590Results posted
• A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) SubjectsCompletedNCT03020745Phase 2Results posted
• Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV InfectionCompletedNCT02981602Phase 2Results posted
• Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-BCompletedNCT02901951Phase 4Results posted
• A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in RussiaCompletedNCT02858440Phase 3Results posted
• 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-deliveryCompletedNCT02853929Phase 4Results posted
• A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During InfancyCompletedNCT02798952Phase 4Results posted
• First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK3389404 in Healthy SubjectsCompletedNCT02647281Phase 1Results posted
• Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy InfantsCompletedNCT02096263Phase 3Results posted
• This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ HexaCompletedNCT02052661Phase 4Results posted
• Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B KinderCompletedNCT01847430Phase 4Results posted
• Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant SystemCompletedNCT01777295Phase 2Results posted
• Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes MellitusCompletedNCT01627340Phase 4Results posted
• Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)CompletedNCT01453998Phase 2Results posted
• Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™CompletedNCT01358825Phase 4Results posted
• Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) VaccineCompletedNCT01353703Phase 3Results posted
• Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)CompletedNCT01345240Phase 3Results posted
• Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated ChildrenCompletedNCT01333813Phase 4Results posted
• HEPSERA Post Marketing SurveillanceCompletedNCT01329419Results posted
• Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)CompletedNCT01300234Phase 3Results posted
• Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)CompletedNCT01248884Phase 2Results posted
• Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster DoseCompletedNCT01171989Phase 2Results posted
• Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated ChildrenCompletedNCT01138098Phase 4Results posted
• Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy ToddlersCompletedNCT01106092Phase 2Results posted
• Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy InfantsCompletedNCT01090453Phase 2Results posted
• Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix AdultCompletedNCT01037114Phase 4Results posted
• Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix AdultCompletedNCT01000324Phase 4Results posted
• Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B VaccinationCompletedNCT00984139Phase 4Results posted
• Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of AgeCompletedNCT00970307Phase 2Results posted
• Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™CompletedNCT00875485Phase 4Results posted
• Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.TerminatedNCT00871741Phase 2Results posted
• Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B VaccineCompletedNCT00805389Phase 2Results posted
• Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.CompletedNCT00774995Phase 4Results posted
• Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in InfantsCompletedNCT00753649Phase 4Results posted
• Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary VaccinationCompletedNCT00684671Phase 4Results posted
• Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive ProceduresTerminatedNCT00678587Phase 3Results posted
• Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B VaccineCompletedNCT00657657Phase 4Results posted
• Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)CompletedNCT00637195Phase 3Results posted
• Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib VaccineCompletedNCT00627458Phase 2Results posted
• Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old ChildrenCompletedNCT00611559Phase 4Results posted
• Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B VaccineCompletedNCT00524576Phase 4Results posted
• Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.CompletedNCT00519649Phase 4Results posted
• Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/HibCompletedNCT00473668Phase 3Results posted
• Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same VaccinesCompletedNCT00463437Phase 3Results posted
• Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.CompletedNCT00456625Phase 4Results posted
• Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 YrsCompletedNCT00343915Phase 3Results posted
• Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed SubjectsCompletedNCT00317109Phase 3Results posted
• Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 StudyCompletedNCT00291343Phase 3Results posted
• Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy AdultsCompletedNCT00289770Phase 3Results posted
• Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month ScheduleCompletedNCT00289744Phase 3Results posted
• Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B VaccCompletedNCT00289731Phase 4Results posted
• Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month ScheduleCompletedNCT00289718Phase 3Results posted
• Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)CompletedNCT00240539Phase 4Results posted
• LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ MothersCompletedNCT00240526Phase 4Results posted
• Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ MothersCompletedNCT00240500Phase 4Results posted
• Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in ChildrenCompletedNCT00228917Phase 3Results posted
• Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were ComparedCompletedNCT00197184Phase 3Results posted
• Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 YearsCompletedNCT00197119Phase 3Results posted
• Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in InfantsCompletedNCT00169442Phase 3Results posted
• Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to InfantsCompletedNCT00158756Phase 3Results posted
• Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30mCompletedNCT00136604Phase 3Results posted
• A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney DiseaseActive, not recruitingNCT07168356Phase 1
• A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)Active, not recruitingNCT06537414Phase 2
• Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)Active, not recruitingNCT06497504Phase 2
• Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)CompletedNCT05630820Phase 3
• Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)CompletedNCT05630807Phase 3
• A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) TherapyCompletedNCT05276297Phase 2
• Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic ImpairmentCompletedNCT04971928Phase 1
• Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)Active, not recruitingNCT04954859Phase 2
• This Study Aims to Determine the Incidence, of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of AgeCompletedNCT02324218
• Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult VolunteersCompletedNCT02153320Phase 1
• 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)WithdrawnNCT02135666Phase 4
• Drug Use Investigation for HEPSERA (Adefovir) TabletCompletedNCT01863589
• Acceptability of Hepatitis B Vaccination in General PopulationCompletedNCT01782794
• Acceptability of Hepatitis B Vaccination in General Practitioners and PaediatriciansCompletedNCT01777074
• Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio VaccineCompletedNCT01457560Phase 3
• Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination CourseCompletedNCT01457547Phase 4
• Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered SeparatelyCompletedNCT01457508Phase 3
• Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered ConcomitantlyCompletedNCT01457495Phase 2
• Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™CompletedNCT01061541Phase 2
• Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib VaccineCompletedNCT00880477Phase 3
• Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy InfantsCompletedNCT00879827Phase 3
• Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected PatientsWithdrawnNCT00782301Phase 4
• Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis PatientsCompletedNCT00699231Phase 1
• Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 yCompletedNCT00698906Phase 2
• Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 yCompletedNCT00698555Phase 2
• Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-BCompletedNCT00698087Phase 3
• Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15yCompletedNCT00698061Phase 3
• Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B VaccineCompletedNCT00697970Phase 3
• Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-RespondersCompletedNCT00697931Phase 3