Clinical trials: HBV
Hepatitis B, Vertical Transmission of Infectious Disease
The COMBAT HBV Feasibility Trial
This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in the Democratic Republic of Congo (DRC).
- Trial name
- COMBAT-HBV (NCT05705427)
- Testing
- Tenofovir Disoproxil Fumarate 300 MG, Hepatitis B monovalent vaccine
- Where
- Democratic Republic of the Congo
- Volunteers
- 317 people
- Sponsor
- University of North Carolina, Chapel Hill
Diphtheria, Hepatitis B
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity…
- Conditions
- Diphtheria, Hepatitis B, Haemophilus Influenzae Type b, Whole Cell Pertussis
- Trial name
- NCT00317161
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- 3 sites in Thailand
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Hepatitis B
Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT01090453
- Testing
- GSK2202083A vaccine, Prevenar 13®, Infanrix hexa™
- Where
- 34 sites in Canada, France and 1 more
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old.
- Trial name
- NCT00435812
- Testing
- Engerix-B
- Where
- 18 sites in Canada, Germany
- Volunteers
- 2,428 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Australia Antigen Positive, Hepatitis B
Optimization of Antiviral Therapy of Chronic HBV Infection
Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible.
- Conditions
- Australia Antigen Positive, Hepatitis B, Adverse Effects
- Trial name
- NCT01623778
- Testing
- Interferon Alfa-2a add on ADV
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Changhai Hospital
Hib Disease, Hepatitis B
Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths
To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine
- Conditions
- Hib Disease, Hepatitis B, Pertussis, Prophylaxis of Diphtheria
- Trial name
- NCT00158808
- Testing
- Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib
- Where
- Philippines
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B Vaccine Adverse Reaction
Efficacy of Hepatitis B Vaccine Boosters Among Neonatally Vaccinated Children in Chongqing
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis, and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma.
- Trial name
- NCT03867643
- Testing
- hepatitis B vaccine(HepB)
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Chongqing Medical University
Hepatitis B
A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials
The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.
- Trial name
- NCT01337479
- Volunteers
- 1,097 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B Virus, Decompensated Cirrhosis
Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis
The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.
- Trial name
- NCT00663182
- Testing
- Entecavir
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Changzheng Hospital
Pain, Analgesia
Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B
Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus…
- Trial name
- NCT00713986
- Testing
- Water 2mL PO 2 minutes prior to intra-muscular injection, skin-to-skin contact, Glucose 25% 2 mL PO 2 minutes prior to injection
- Volunteers
- 640 people
- Sponsor
- Federal University of São Paulo
Diphtheria, Tetanus
Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
The purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT 00362336).
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01105559
- Where
- 2 sites in South Africa
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatitis B
Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib
Persistence of seroprotective antibody concentrations \& immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine
- Trial name
- NCT00356564
- Testing
- hepatitis B vaccine
- Where
- 42 sites in Germany
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Immunization, DTaP Vaccine
Comparison of Immunization Quality Improvement Dissemination Study
Dissemination research examines the processes and factors that lead to widespread use of evidence-based interventions. There are several theories on how to best minimize the perceived and actual burdens on practitioners…
- Conditions
- Immunization, DTaP Vaccine, Hepatitis B Vaccine, MMR Vaccine
- Trial name
- CIzQIDS (NCT02432430)
- Testing
- QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage, Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage
- Volunteers
- 2,186 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Liver Injury, Hepatitis B Virus Infection History
Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection
The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.
- Trial name
- LISHBV (NCT02808299)
- Testing
- HBV infection history
- Where
- China
- Volunteers
- 600 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Healthy Infants
A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to…
- Trial name
- NCT01896739
- Testing
- Eutravac
- Where
- 7 sites in South Korea
- Volunteers
- 289 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Malaria
Phase Ib Trial of MSP3 LSP in Children in Tanzania
This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission.
- Trial name
- MSP3TN (NCT00469651)
- Testing
- MSP 3 Long Synthetic Peptide, MSP3 vaccine, Hepatitis B vaccine
- Where
- Tanzania
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- African Malaria Network Trust
Chronic Hepatitis B
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the…
- Trial name
- NCT00057265
- Testing
- telbivudine or lamivudine
- Where
- 11 sites in United States, South Korea and 4 more
- Sponsor
- Novartis
Hepatitis B, Immunization; Infection
Hepatitis B Birth Dose for Newborns
With 2.5% prevalence in general population, Pakistan is an intermediate endemicity country for hepatitis B. However, wide disparity exists across the country as disease prevalence in general population soars as high as 14% in…
- Trial name
- HepB-BirD (NCT04870021)
- Testing
- recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm),, Short text messages and calls to parents for compliance to routine immunization schedule
- Where
- Pakistan
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Quaid-e-Azam University
Chronic Hepatitis B
Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients
Patients with chronic hepatitis B constantly produce the virus in the body. The disease of chronic hepatitis B is the body responding to the virus. Use of steroids can adjust this response.
- Trial name
- NCT00715715
- Testing
- Prednisone Priming
- Where
- United States
- Sponsor
- Maimonides Medical Center
the Safety of Anti-viral Drugs Used in Late Pregnancy
The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children
Mother to child transmission(MTCT) is the main route of hepatitis B virus(HBV) transmission.High HBV DNA level of pregnant women is the main risk factor of MTCT.
- Trial name
- NCT02301650
- Testing
- Lamivudine, Telbivudine, Tenofovir
- Volunteers
- 400 people
- Sponsor
- Beijing Ditan Hospital