Clinical trials: HBV Infection
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Chronic Hepatitis B
Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients
This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB.
- Trial name
- NCT00441974
- Testing
- adefovir dipivoxil
- Where
- 25 sites in China
- Volunteers
- 1,470 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of…
- Trial name
- NCT00095121
- Testing
- Adefovir Dipivoxil (ADV), Lamivudine
- Where
- United States
- Volunteers
- 173 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past.
- Trial name
- NCT00487747
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 23 sites in Russia
- Volunteers
- 18 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to determine whether ARC-520 in combination with entecavir is effective in the treatment of patients with chronic HBV Infection.
- Trial name
- NCT02065336
- Testing
- ARC-520, entecavir, chlorpheniramine
- Where
- 2 sites in Hong Kong
- Volunteers
- 58 people
- Sponsor
- Arrowhead Pharmaceuticals
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
Chronic Hepatitis B
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931.
- Trial name
- NCT03038113
- Testing
- RO7062931, Immune Modulator
- Where
- 19 sites in Australia, Hong Kong and 5 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in…
- Trial name
- NCT01153841
- Testing
- Synflorix™( GSK1024850A), Infanrix hexa™
- Where
- Vietnam
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis, Hepatitis B, Chronic
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the…
- Conditions
- Hepatitis, Hepatitis B, Chronic, Cirrhosis
- Trial name
- NCT00076336
- Testing
- Telbivudine, Lamivudine
- Where
- 28 sites in United States, Australia and 19 more
- Volunteers
- 232 people
- Sponsor
- Novartis Pharmaceuticals
Infections, Meningococcal, Meningococcal Vaccines
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age.
- Trial name
- NCT01144663
- Testing
- Nimenrix™, Menjugate®, NeisVac-CTM
- Where
- 44 sites in Estonia, Germany and 1 more
- Volunteers
- 2,095 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Suboptimal Responders to Adefovir Switching to Entecavir
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
- Trial name
- NCT00718887
- Testing
- Entecavir, Adefovir/Entecavir
- Where
- 8 sites in China
- Volunteers
- 228 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B.
- Trial name
- NCT00435825
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 55 sites in United States, Australia and 11 more
- Volunteers
- 551 people
- Sponsor
- Hoffmann-La Roche
Chronic Kidney Disease
Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
- Trial name
- NCT00985426
- Testing
- HEPLISAV-B, Engerix-B
- Where
- United States
- Volunteers
- 521 people
- Sponsor
- Dynavax Technologies Corporation
Hepatitis B, Hepatitis A
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis…
- Trial name
- NCT00289718
- Testing
- Twinrix™ adult
- Where
- Belgium
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Healthy
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
- Trial name
- NCT02117934
- Testing
- HEPLISAV, Engerix-B
- Where
- 40 sites in United States
- Volunteers
- 8,374 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Infections, Streptococcal
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by…
- Trial name
- NCT01204658
- Testing
- Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2), Synflorix
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 576 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01519960
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 39 sites in United States, Australia and 10 more
- Volunteers
- 165 people
- Sponsor
- Hoffmann-La Roche