Clinical trials: HBV Infection
Hepatitis B
Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection
Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.
- Trial name
- NCT02738008
- Testing
- ARC-520 Injection, entecavir, tenofovir
- Where
- 6 sites in China, Germany and 1 more
- Volunteers
- 12 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B, Chronic Disease
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.
- Trial name
- NCT00096785
- Testing
- entecavir, adefovir
- Where
- 24 sites in United States, Canada and 6 more
- Volunteers
- 69 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.
- Trial name
- NCT03780543
- Testing
- standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 92 people
- Sponsor
- Assembly Biosciences
Chronic Hepatitis B
Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment
Background: Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but the virus can be controlled with the use of antiviral medicines,.
- Trial name
- NCT02364336
- Testing
- Peginterferon alfa-2a
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis B
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.
- Trial name
- INSIGHT (NCT04585789)
- Testing
- JNJ-73763989, JNJ-56136379, Entecavir (ETV)
- Where
- 10 sites in United States, Belgium and 7 more
- Volunteers
- 24 people
- Sponsor
- Janssen Research & Development, LLC
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
Chronic Hepatitis B
A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection
The purpose of this study is to evaluate the antiviral activity and safety of tenofovir disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in the United States) with chronic hepatitis B…
- Trial name
- NCT00736190
- Testing
- Tenofovir disoproxil fumarate
- Where
- 21 sites in United States
- Volunteers
- 90 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in…
- Trial name
- NCT03434353
- Testing
- Inarigivir Soproxil, TAF
- Where
- 13 sites in Hong Kong, South Korea
- Volunteers
- 123 people
- Sponsor
- Gilead Sciences
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
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine.
- Trial name
- NCT01341639
- Testing
- V419, INFANRIX™ hexa, RotaTeq
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Hepatitis B, Chronic
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs).
- Trial name
- NCT02195518
- Testing
- Tenofovir disoproxil fumarate
- Where
- 12 sites in China
- Volunteers
- 213 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic, Chronic Hepatitis B
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814.
- Trial name
- NCT00403585
- Testing
- adefovir dipivoxil 10mg
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
The aim of this Observer-blind study is to compare different Adjuvant Systems with the same, well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B (Engerix-BTM and FendrixTM), in order to better…
- Trial name
- NCT00805389
- Testing
- Engerix-B™, Fendrix™, GSK Biologicals' Hepatitis B vaccines (GSK223192A)
- Where
- 14 sites in Belgium, Germany
- Volunteers
- 713 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Hepatitis B, Hepatitis A
Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™
This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received vaccination course with GSK…
- Trial name
- NCT00875485
- Testing
- Blood sampling, Additional challenge dose
- Where
- 2 sites in Belgium, Czechia
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Acellular Pertussis
Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal…
- Conditions
- Hepatitis B, Acellular Pertussis, Tetanus, Poliomyelitis
- Trial name
- NCT00463437
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Prevenar, Infanrix hexa
- Where
- 63 sites in Germany, Poland and 1 more
- Volunteers
- 1,437 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF arm) compared to participants who continue TDF…
- Trial name
- FINITE CHB (NCT01320943)
- Testing
- TDF, Stop TDF
- Where
- 13 sites in Germany
- Volunteers
- 43 people
- Sponsor
- Gilead Sciences
Hepatitis B
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
Patients with chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
- Trial name
- NCT02604199
- Testing
- ARC-520 Injection, entecavir, tenofovir
- Where
- 16 sites in China, Germany and 1 more
- Volunteers
- 58 people
- Sponsor
- Arrowhead 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 Virus Infection
A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B…
- Trial name
- NCT03762681
- Testing
- RO7239958
- Where
- 14 sites in Bulgaria, Hong Kong and 5 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche