Clinical trials: Chronic Hepatitis B Infections
Chronic Hepatitis B
3E Extension Study
The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.
- Trial name
- 3E Ex (NCT01834508)
- Testing
- oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
- Where
- 28 sites in China
- Volunteers
- 600 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Chronic Hepatitis B Virus Infection
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV).
- Trial name
- NCT07389044
- Testing
- IB-001, Peginterferon Alfa-2A
- Where
- 5 sites in Hong Kong, Moldova and 2 more
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- IntegerBio
Hepatitis B, Chronic
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
This is a prospective, multicentre observational study of Chronic Hepatitis B （CHB）in different clinical stages. We intend to compare the immune status of various types of CHB patients, and we propose to establish a staging and…
- Trial name
- NCT06525909
- Where
- 5 sites in China
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Tongji Hospital
Chronic Hepatitis B
A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
A Randomized Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
- Trial name
- NCT04485663
- Testing
- ALG-010133
- Where
- 10 sites in China, Hong Kong and 4 more
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
For Treatment of Chronic Hepatitis B Virus Infection
Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)
This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase…
- Trial name
- NCT06491563
- Testing
- BRII-179, BRII-835 (VIR-2218), PEG-IFNα
- Where
- 12 sites in China
- Volunteers
- 150 people
- Sponsor
- Brii Biosciences Limited
Hepatitis B, Chronic, Fibrosis
Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV…
- Trial name
- NCT02327689
- Testing
- Emtricitabine plus adefovir dipivoxil
- Volunteers
- 400 people
- Sponsor
- Asian-Pacific Alliance of Liver Disease, Beijing
Hepatitis B, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)
This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B.
- Trial name
- NCT01283074
- Where
- 16 sites in Greece
- Volunteers
- 107 people
- Sponsor
- Hoffmann-La Roche
Acute Liver Failure, Acute Liver Injury
Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: safety and tolerability; metabolism of the compound to glutamine and…
- Trial name
- STOP-ALF (NCT01548690)
- Testing
- Ornithine Phenylacetate
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- William Lee
Chronic Hepatitis B
Tenofovir in Asian Chronic Hepatitis B Patients
Tenofovir (TDF) has been demonstrated to have potency antiviral against the hepatitis B virus (HBV) in various multiple-centre trials, with no cases of resistance encountered.
- Trial name
- NCT01728935
- Testing
- Tenofovir disoproxil
- Where
- Hong Kong
- Volunteers
- 141 people
- Sponsor
- The University of Hong Kong
Hepatitis B, Chronic
EYP001a Food Effect Study in Subjects With Chronic Hepatitis B Virus (HBV) Infection
The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B.
- Trial name
- NCT03320616
- Testing
- EYP001a
- Where
- Netherlands
- Volunteers
- 11 people
- Sponsor
- Enyo Pharma
Hepatitis B, ESRD (End Stage Renal Disease)
Comparing Hepatitis B Vaccination Schedules in Patients on Hemodialysis
People with kidney failure who are on dialysis have a weaker immune response to the hepatitis B vaccine than healthy people. Even after vaccination, many dialysis patients do not develop enough protection against hepatitis B…
- Conditions
- Hepatitis B, ESRD (End Stage Renal Disease), Kidney Failure, Chronic
- Trial name
- 3v4-HEP-DOSE (NCT07784452)
- Testing
- Recombinant Hepatitis B Vaccine - 3-Dose Schedule, Recombinant Hepatitis B Vaccine - 4-Dose Schedule
- Where
- Pakistan
- Volunteers
- 104 people
- Sponsor
- Jinnah Hospital
Chronic Hepatitis B
A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection
The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with…
- Trial name
- NCT04781647
- Testing
- ABI-H0731, ETV, Peg-IFNα
- Where
- 9 sites in China
- Volunteers
- 54 people
- Sponsor
- Assembly Biosciences
Hepatitis B
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic…
- Trial name
- HBRN (NCT01369212)
- Testing
- Tenofovir, Peginterferon-alfa 2a and tenofovir
- Where
- 21 sites in United States, Canada
- Volunteers
- 201 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Chronic Hepatitis B Infection
The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral Therapy
Pegylated interferon(IFN) α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while entecavir(ETV) drugs only inhibit viral replication.
- Trial name
- NCT03210467
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Beijing Ditan Hospital
Hepatitis D, Chronic
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.
- Trial name
- REEF-D (NCT04535544)
- Testing
- JNJ-73763989, Entecavir (ETV) monohydrate, Tenofovir disoproxil
- Where
- 61 sites in United States, Australia and 13 more
- Volunteers
- 52 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis B, Chronic
Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection
A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed participants under nucleo(s)tide treatment.
- Trial name
- NCT03866187
- Testing
- ChAd155-hIi-HBV low dose formulation, ChAd155-hIi-HBV high dose formulation, HBc-HBs/AS01B-4 low dose formulation
- Where
- 43 sites in Belgium, France and 7 more
- Volunteers
- 236 people
- Sponsor
- GlaxoSmithKline
HBeAg(+) Chronic Hepatitis B
A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+)
A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine and peg-interferon sequential treatment in…
- Trial name
- NCT01264367
- Testing
- Clevudine, Clevudine + Peg-interferon
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Bukwang Pharmaceutical
Chronic Hepatitis B Infection
The Changes of CD4+T Cells Frequency and Function During Antiviral Therapy
Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication.
- Trial name
- NCT03209011
- Testing
- Peginterferon Alfa-2a
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Yao Xie
Chronic HBV Infection
Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of PA1010 in HBV Patients
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of multiple ascending dose (MAD) of PA1010 tablets in Chinese adults with Chronic Hepatitis B.
- Trial name
- NCT05019040
- Testing
- PA1010
- Where
- 4 sites in China
- Volunteers
- 36 people
- Sponsor
- Zhejiang Palo Alto Pharmaceuticals, Inc.
Hepatitis B, Chronic
Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients
A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.
- Trial name
- NCT04133259
- Testing
- Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody, Nucleoside/nucleotide analogues
- Where
- 3 sites in Taiwan
- Volunteers
- 44 people
- Sponsor
- Henlix, Inc
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