Clinical trials: Viral Hepatitis B
Poliomyelitis, Diphtheria
Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar…
- Conditions
- Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Tetanus
- Trial name
- NCT02096263
- Testing
- Infanrix hexa, Pediarix, ActHIB
- Where
- 43 sites in United States
- Volunteers
- 585 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects
GSK3389404 is being developed for the treatment of CHB virus infection. The development goal for GSK3389404 is the establishment of a finite duration treatment that results in sustained suppression of hepatitis B virus (HBV)…
- Trial name
- NCT03020745
- Testing
- GSK3389404
- Where
- 21 sites in China, Hong Kong and 4 more
- Volunteers
- 78 people
- Sponsor
- GlaxoSmithKline
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
Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.
- Trial name
- NCT05808374
- Testing
- HRS-5635
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Hepatitis B, Chronic, Pregnancy Related
Chronic HBV Infection in Pregnant Women Taking TAF to Prevent Vertical Transmission
Mother-to-child transmission is the main route of transmission of Hepatitis B Virus (HBV) in China, and about 30% - 50% of chronic HBV carriers are infected by this.
- Trial name
- NCT04237376
- Testing
- Tenofovir Alafenamide 25 MG, Tenofovir Disoproxil Fumarate 300 MG Oral Tablet
- Where
- 4 sites in China
- Volunteers
- 600 people
- Sponsor
- New Discovery LLC
Chronic Hepatitis B
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects
This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir.
- Trial name
- NCT06990776
- Testing
- TQA3605 Tablets, Entecavir dispersible tablets
- Where
- 29 sites in China
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chronic Hepatitis b
Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers
A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with reference formulation entecavir tablets (Baraclude®)…
- Trial name
- NCT03847246
- Testing
- Baraclude® tablets,1.0 mg, Entecavir tablets,1.0 mg
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24…
- Trial name
- ASTRAL-4 (NCT02201901)
- Testing
- SOF/VEL, RBV
- Where
- 50 sites in United States, Puerto Rico
- Volunteers
- 268 people
- Sponsor
- Gilead Sciences
Hepatitis B
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine…
- Trial name
- NCT00440531
- Testing
- Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), Comparator: Modified Process Hepatitis B Vaccine (Experimental), Comparator: ENGERIX-B™ (currently licensed product)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Vaccine-Preventable Diseases, Hepatitis B
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002.
- Trial name
- CVI-HBV-002 (NCT06147895)
- Testing
- CVI-HBV-002
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Aribio Lab Co., Ltd.
Diphtheria, Tetanus
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00348881
- Testing
- DTaP-HB-PRP~T combined vaccine, Tritanrix-HepB/Hib™ vaccine, Oral poliomyelitis vaccine (OPV)
- Where
- 4 sites in Philippines
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
HBV, Chronic HBV Infection
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis…
- Trial name
- NCT02836249
- Testing
- TAF, TDF
- Where
- 25 sites in China
- Volunteers
- 181 people
- Sponsor
- Gilead Sciences
Hepatitis B Infection
A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process.
- Trial name
- NCT00489099
- Testing
- V232 Modified Process Hepatitis B Vaccine: Lot A, V232 Modified Process Hepatitis B Vaccine: Lot B, V232 Modified Process Hepatitis B Vaccine: Lot C
- Volunteers
- 860 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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.
Hepatitis B, Chronic
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.
- Trial name
- NCT01475851
- Testing
- GSK548470 300 mg tablet
- Where
- 11 sites in Japan
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection
IMC-I109V is an immune-mobilizing monoclonal T cell receptor (TCR) against viruses (ImmTAV®), a new class of bispecific protein therapeutics designed for the treatment of chronic hepatitis B virus (HBV) infection (CHB).
- Trial name
- NCT05867056
- Testing
- IMC-I109V Single Ascending Dose, IMC-I109V Multiple Ascending Doses, HBV HCC Module MAD
- Where
- 15 sites in United States, Australia and 7 more
- Sponsor
- Immunocore Ltd
Chronic Hepatitis B
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.
- Trial name
- NCT01264094
- Testing
- Clevudine
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Bukwang Pharmaceutical
Chronic Hepatitis B
A Phase I, the Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults ≥18 years…
- Trial name
- NCT06162299
- Testing
- YS-HBV-002
- Where
- Philippines
- Volunteers
- 16 people
- Sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.
HIV Coinfection
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
- Trial name
- NCT01327547
- Testing
- Maraviroc
- Where
- 48 sites in United States, Czechia and 7 more
- Volunteers
- 138 people
- Sponsor
- ViiV Healthcare
Chronic Hepatitis B
A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .
- Trial name
- NCT06311734
- Testing
- LW231 tablets
- Where
- China
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Shanghai Longwood Biopharmaceuticals Co., Ltd.