Clinical trials: Hepatitis B Infections
Chronic Hepatitis B
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.
- Trial name
- NCT00140725
- Testing
- Lamivudine plus Polyethylene glyco-interferon alfa-2b, Lamivudine
- Where
- Hong Kong
- Volunteers
- 160 people
- Sponsor
- GlaxoSmithKline
Liver Diseases, Hepatitis, Chronic
Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to collect epidemiological data in children and adolescents with chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with associated ALT levels , active HBeAg…
- Conditions
- Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepatitis
- Trial name
- EPIC B (NCT01163240)
- Where
- 86 sites in United States, Argentina and 16 more
- Volunteers
- 1,640 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B Vaccine
Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B
The purpose of this study is to assess the long-term protection against HBV infection in adult subjects, aged 18-40 years vaccinated with three or four doses of Engerix-B 20 to 30 years ago
- Trial name
- NCT02901951
- Testing
- Engerix-B
- Where
- 4 sites in Belgium, Canada
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤…
- Trial name
- NCT00426712
- Testing
- 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen, Hepatitis B Vaccine (Recombinant)
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- Dynavax Technologies Corporation
Hepatitis B Vaccines
Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45…
- Trial name
- NCT03393754
- Testing
- Hepatitis B Vaccination
- Where
- 28 sites in United States, Belgium and 2 more
- Volunteers
- 1,607 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Hepatitis B, Polio
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00401531
- Testing
- DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines, DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
- Where
- 2 sites in Thailand
- Volunteers
- 412 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Hepatitis A
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 Years
To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00197119
- Testing
- Twinrix™ Adult, Twinrix™ Junior
- Where
- 2 sites in Belgium, Czechia
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule
Hepatitis B virus (HBV) infection is an important global health problem, and the WHO adopted a strategy to eliminate HBV infection as a public health threat by the year 2030.
- Trial name
- NEOVAC2BK (NCT04029454)
- Testing
- birth dose vaccination against hepatitis B strategy
- Where
- 2 sites in Burkina Faso
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Chronic Hepatitis B
Bioequivalence Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers
After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331.
- Trial name
- NCT02300688
- Testing
- Treatment A, Treatment B
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Chronic HBV Infection
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514.
- Trial name
- NCT04470388
- Testing
- EDP-514
- Where
- 10 sites in Hong Kong, Taiwan
- Volunteers
- 25 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Chronic Hepatitis B
Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients With Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized…
- Trial name
- NCT06744686
- Testing
- HT-102
- Where
- 7 sites in China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Suzhou HepaThera Biotech Co., Ltd.
Hepatitis B
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from…
- Trial name
- NCT05561673
- Testing
- GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system, GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults.
- Trial name
- Chinese PAC (NCT00781105)
- Testing
- Telbivudine
- Where
- China
- Volunteers
- 2,200 people
- Sponsor
- Novartis Pharmaceuticals
Bacterial Infections; Virus Diseases
A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4 different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria…
- Trial name
- NCT00551629
- Testing
- AR51 (12, 10), PR51 (3, 10), PR51 (6, 10)
- Volunteers
- 708 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B, Chronic, Pregnancy Related
Maternal Therapy With TAF Versus TDF to Prevent Vertical Transmission of Hepatitis B
Immunoprophylaxis failure of hepatitis B (HBV) remains a concern and has been reported in approximately 10-30% of infants born to highly viremic mothers with HBeAg-positive.
- Trial name
- NCT04211805
- Testing
- Tenofovir Alafenamide 25 MG for arm (A), Tenofovir Disoproxil Fumarate 300mg for arm (B)
- Where
- 11 sites in China
- Volunteers
- 450 people
- Sponsor
- New Discovery LLC
Hepatitis B
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo.
- Trial name
- NCT02797522
- Testing
- ARC-521 Injection, antihistamine, acetaminophen
- Where
- New Zealand
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Poliomyelitis, Tetanus
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT01353703
- Testing
- Infanrix hexa™
- Where
- 4 sites in India
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatocellular Carcinoma
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986.
- Trial name
- NCT00322361
- Testing
- Comparator: RECOMBIVAX HB™, Comparator: Modified process Hepatitis B Vaccine
- Volunteers
- 566 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B
A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B
- Trial name
- NCT06263959
- Testing
- GST-HG131
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
Chronic Hepatitis b
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.
- Trial name
- NCT05960240
- Testing
- AB-101, Nucleos(t)ide Analogue
- Where
- 10 sites in Hong Kong, Italy and 5 more
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Arbutus Biopharma Corporation