Clinical trials: Hepatitis B Virus Infection
Chronic Hepatitis B
Phase 3 and Extensional Study of Besifovir
To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or…
- Trial name
- NCT01937806
- Testing
- besifovir 150mg, tenofovir 300mg
- Where
- 20 sites in South Korea
- Volunteers
- 197 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
Hepatitis A
Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus…
- Trial name
- NCT00197236
- Testing
- Havrix™, Infanrix™, ActHIB™
- Where
- 22 sites in United States
- Volunteers
- 468 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in patients with HbeAg negative chronic hepatitis…
- Trial name
- NCT01179594
- Testing
- entecavir, peginterferon alfa-2a [Pegasys]
- Sponsor
- Hoffmann-La Roche
Hepatocellular Carcinoma, Hepatitis B
Identification of Biomarkers Associated With Human Hepatocellular Carcinoma by SELDI
Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for diagnosis of HCCs.
- Conditions
- Hepatocellular Carcinoma, Hepatitis B, Hepatitis C
- Trial name
- NCT00154531
- Where
- Taiwan
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Diphtheria, Tetanus
The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks
The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT03931239
- Testing
- Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval
- Where
- Vietnam
- Volunteers
- 222 people, healthy volunteers welcome
- Sponsor
- Vabiotech
Chronic Hepatitis B
Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate.
- Trial name
- NCT01243281
- Testing
- PEG-IFN and entecavir
- Where
- Thailand
- Volunteers
- 126 people
- Sponsor
- Chulalongkorn University
Chronic Hepatitis C, Decompensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
- Conditions
- Chronic Hepatitis C, Decompensated Cirrhosis, Hepatitis C Virus
- Trial name
- TURQUOISE-CPB (NCT02219477)
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Volunteers
- 36 people
- Sponsor
- AbbVie
Diphtheria, Tetanus
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b Infection
- Trial name
- NCT02094833
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV//PRP~T and Hepatitis B vaccine
- Where
- 16 sites in South Korea
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.
- Trial name
- NCT01760122
- Testing
- Ypeginterferon alfa-2b, Pegasys
- Where
- 43 sites in China
- Volunteers
- 820 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Chronic Hepatitis B
Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients
A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.
- Trial name
- NCT00558493
- Testing
- Clevudine
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Bukwang Pharmaceutical
Hepatitis B, Chronic
Hepatitis B Virus Mutants and the Therapeutic Effect of Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B
In order to clarify the association between HBV mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive CHB patients undergoing peginterferon alfa-2a…
- Trial name
- NCT01311947
- Testing
- Peginterferon alfa-2a
- Where
- Taiwan
- Volunteers
- 103 people
- Sponsor
- China Medical University Hospital
Hepatitis B, HBV
Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor
An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B e antigen (HBeAg)-negative subjects with chronic HBV infection.
- Conditions
- Hepatitis B, HBV, Hepatitis B, Chronic
- Trial name
- NCT04023721
- Testing
- Inarigivir soproxil, Nucleoside/nucleotide (NUC) analogue inhibitors
- Where
- 7 sites in Canada, United Kingdom
- Volunteers
- 64 people
- Sponsor
- F-star Therapeutics, Inc.
Chronic Hepatitis B
An Exploratory Study of RGT Strategy on Optimal NUC-experienced Patients
The aim of current study is to investigate whether the HBsAg clearance rate can be improved if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis B) patients treated by nucleoside…
- Trial name
- NCT02560649
- Testing
- Peginterferon alfa-2a plus Entecavir, Peginterferon alfa-2a plus Lamivudine, Peginterferon alfa-2a plus Adefovir
- Volunteers
- 324 people
- Sponsor
- Ruijin Hospital
Hepatitis B, Haemophilus Influenzae Type b Immunisation
Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea
Primary objectives: To investigate the incidence of adverse events occurred following administration of Hexaxim in infants from 2 months of age under routine clinical practice, as per approved indications
- Trial name
- NCT06793826
- Testing
- DTaP-IPV-Hep B-PRP-T combined vaccine
- Where
- 2 sites in South Korea
- Volunteers
- 713 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Chronic
Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination…
- Trial name
- PEG-Tα1 (NCT02366208)
- Testing
- PEG-Tα1, Adefovir
- Where
- 12 sites in China
- Volunteers
- 116 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hepatitis B
Evaluation of Hepatitis B Virus (HBV) DNA Test As Point of Care Tool
This is a cross sectional observational study to asses the performance of two novel HBV DNA testing methodologies; a) dried blood spot sampling and b) fingerstick capillary blood using the Xpert® Hepatitis B Virus viral load…
- Trial name
- HBVPOCT (NCT05144776)
- Testing
- GeneXpert HBV DNA Viral Load Assay, Dried Blood Spot HBV DNA test
- Where
- 6 sites in Australia
- Volunteers
- 268 people
- Sponsor
- Kirby Institute
Chronic Hepatitis B
The Safety and Tolerability of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.
- Trial name
- NCT03173599
- Testing
- PNA 40mg, PNA 80mg, PNA 160mg
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
Chronic Hepatitis B
Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy
This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal.
- Trial name
- NCT02594293
- Testing
- PegIFN alfa-2a
- Where
- 19 sites in China
- Volunteers
- 180 people
- Sponsor
- Huashan Hospital
Tetanus, Diphtheria
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination…
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT00970307
- Testing
- GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A), Infanrix hexa™
- Where
- 9 sites in Poland
- Volunteers
- 421 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Liver Transplantation
Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation
The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.
- Trial name
- NCT02417207
- Testing
- Entecavir combined long-term low-dose HBIG group intramuscular, Entecavir combined HBIG group short-term high-dose intravenous
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University