Clinical trials: Hepatitis b Virus
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, 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
Hepatitis B Virus (HBV)
Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients
A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.
- Trial name
- NCT04189276
- Testing
- ETV/TDF+T101 No.1, ETV/TDF+T101 No.2, ETV or TDF
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Tasly Tianjin Biopharmaceutical Co., Ltd.
Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with…
- Trial name
- NCT07606950
- Testing
- HRS-5635 Injection
- Where
- China
- Volunteers
- 540 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
HBV Infection
Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B
This is a multicenter, open-label, non-randomized, Phase 1 clinical study with single-dose and multiple-dose dose-escalation cohorts.
- Trial name
- NCT07673068
- Testing
- TVAX-028, Adjuvant
- Volunteers
- 32 people
- Sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.
Chronic HBV Infection
A Long-term Observational Study in Participants Who Have Received PBGENE-HBV
Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study.
- Trial name
- ELIMINATE-B (NCT07254208)
- Testing
- PBGENE-HBV
- Where
- 4 sites in United States, Hong Kong and 2 more
- Volunteers
- 45 people
- Sponsor
- Precision BioSciences, Inc.
Hepatitis B
A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants
This is an open-label, randomized study to investigate subcutaneous (SC) bepirovirsen when delivered via SC injection from vial or Prefilled syringe fitted with a Safety syringe device (PFS SSD) in healthy adult participants.
- Trial name
- NCT06058390
- Testing
- Bepirovirsen
- Where
- 2 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with…
- Trial name
- NCT02979613
- Testing
- TAF, TDF
- Where
- 39 sites in United States, Canada and 6 more
- Volunteers
- 490 people
- Sponsor
- Gilead Sciences
Chronic Viral Hepatitis B With Delta-agent
Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with Chronic Viral Hepatitis B with Delta-agent
- Trial name
- NCT02888106
- Testing
- Myrcludex B, PEG IFN alfa-2a, Tenofovir
- Where
- 7 sites in Russia
- Volunteers
- 90 people
- Sponsor
- Hepatera Ltd.
Hepatitis B
Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection
This Phase 1/2a multiple part study is a first time-in-human (FTIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of GSK3965193 in healthy…
- Trial name
- NCT05330455
- Testing
- GSK3965193, Bepirovirsen
- Where
- 14 sites in Canada, France and 4 more
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Whole Cell Pertussis, Tetanus
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24…
- Conditions
- Whole Cell Pertussis, Tetanus, Hepatitis B, Diphtheria
- Trial name
- NCT00228917
- Testing
- Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, Mencevax-ACWY
- Where
- 2 sites in Philippines, Thailand
- Volunteers
- 798 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
HBV, Hepatitis B
Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients
A single center, open-label, study to evaluate the intra-hepatic effect of inarigivir dose per day and three times per week on immune response and viral markers in virally suppressed patients with chronic hepatitis B infection
- Conditions
- HBV, Hepatitis B, Hepatitis B, Chronic
- Trial name
- NCT03932513
- Testing
- inarigivir soproxil
- Where
- Singapore
- Volunteers
- 8 people
- Sponsor
- F-star Therapeutics, Inc.
Hepatitis B, Chronic
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and…
- Trial name
- NCT00927082
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 31 sites in Australia, Brazil and 8 more
- Volunteers
- 383 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144.
- Trial name
- NCT02258581
- Testing
- GS-4774, GS-9620, Tenofovir disoproxil fumarate (TDF)
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 241 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B in Adults and Paediatric Patients
Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose, fully replicate, bioequivalence study in normal, healthy…
- Trial name
- NCT06592300
- Testing
- Tenofovir Alafenamide Film coated Tablet, Vemlidy® film-coated tablets
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Hepatitis B, Chronic
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal…
- Trial name
- SALMONS (NCT05550519)
- Testing
- Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF)
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Chronic Hepatitis b
A Study to Investigate the Safety, Efficacy and Pharmacokinetic Profile of Multiple Doses of QL-007 in Chronic Hepatitis B Patients
This is a nonrandomized, open-label, no-control, dose-escalation Phase 1b trial in 18 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of QL-007 after administration…
- Trial name
- NCT03244085
- Testing
- QL-007 tablet
- Where
- New Zealand
- Volunteers
- 18 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Diptheria Immunization, Tetanus Immunization
Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing…
- Conditions
- Diptheria Immunization, Tetanus Immunization, Pertussis Immunization, Hepatitis B Immunization
- Trial name
- NCT06413121
- Testing
- Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV, Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV
- Where
- 11 sites in Bangladesh, India
- Volunteers
- 1,557 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Hepatitis B
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.
- Trial name
- NCT00044135
- Testing
- clevudine (drug)
- Where
- 11 sites in United States, Canada and 3 more
- Volunteers
- 30 people
- Sponsor
- Triangle Pharmaceuticals