Clinical trials: HBV Infection
Hepatitis B, Healthy
First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication.
- Trial name
- NCT04297917
- Testing
- ChAdOx1-HBV
- Where
- 4 sites in United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Barinthus Biotherapeutics
Hepatitis B
Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania
Chronic Hepatitis B virus (HBV) infection is a neglected disease with devastating consequences, particularly in countries with limited resources for the health sector.
- Trial name
- HBVPMTCT (NCT04325542)
- Testing
- HBSAg (sure screen test)
- Where
- Tanzania
- Volunteers
- 743 people
- Sponsor
- Medical Mission Institute, Germany
Hepatitis B, Chronic
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and…
- Trial name
- NCT00927082
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 31 sites in Australia, Brazil and 8 more
- Volunteers
- 383 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Study of Telbivudine in Chronic Hepatitis B
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (<=300 copies/ml or 60IU/ml, undetectable by current polymerase…
- Trial name
- NCT00970216
- Testing
- Telbivudine
- Where
- Taiwan
- Volunteers
- 160 people
- Sponsor
- Chang Gung Memorial Hospital
Chronic Hepatitis B
Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection.
- Trial name
- NCT00388674
- Testing
- entecavir, Other anti-HBV medication
- Where
- 290 sites in United States, Argentina and 22 more
- Volunteers
- 12,522 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine
To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago.
- Trial name
- NCT00524576
- Testing
- Engerix™-B
- Where
- 3 sites in Australia, Belgium
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
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™ Hexa
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in infancy and to assess the anamnestic response…
- Trial name
- NCT02052661
- Testing
- Engerix™-B Kinder
- Where
- 11 sites in Germany
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01444781
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Hepatitis A
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 Compared
To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00197184
- Testing
- Twinrix™ Adult, Twinrix™ Junior
- Where
- 7 sites in Australia, Belgium and 1 more
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01948193
- Testing
- Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine
- Where
- 2 sites in India
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)
- Trial name
- NCT03577171
- Testing
- ABI-H0731, SOC ETV
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 25 people
- Sponsor
- Assembly Biosciences
Hepatitis B Vaccine
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone…
- Trial name
- NCT02991599
- Testing
- 60 µg dose hepatitis B vaccine, 20 µg dose hepatitis B vaccine
- Volunteers
- 196 people
- Sponsor
- Shanxi Medical University
Hepatitis B, Chronic
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0…
- Trial name
- NCT00536263
- Testing
- pegylated interferon alpha-2b
- Volunteers
- 671 people
- Sponsor
- Merck Sharp & Dohme LLC
HBV (Hepatitis B Virus), Hepatitis B
Lamivudine and Adefovir to Treat Chronic Hepatitis B
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection.
- Conditions
- HBV (Hepatitis B Virus), Hepatitis B, Hepatitis
- Trial name
- NCT00023309
- Testing
- Lamivudine and adefovir, Adefovir alone
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis B
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents.
- Trial name
- NCT02479880
- Testing
- Tenofovir DF, DEXA Scan
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept
The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients.
- Trial name
- NCT01379508
- Testing
- telbivudine, tenofovir disoproxil fumarate
- Where
- 34 sites in Austria, Bulgaria and 6 more
- Volunteers
- 241 people
- Sponsor
- Novartis Pharmaceuticals
Immunologic Tests
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
- Trial name
- NCT01098006
- Testing
- Blood withdrawal
- Where
- 2 sites in Belgium
- Volunteers
- 99 people
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Tetanus
Immunogenicity and Safety Study 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 evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA…
- Conditions
- Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT02422264
- Testing
- Infanrix hexa, Prevnar13
- Where
- 30 sites in Australia, Canada and 4 more
- Volunteers
- 601 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline