Clinical trials: Hepatitis B Virus Infection
Chronic Hepatitis, Hepatitis B
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.
- Trial name
- QUASH2 (NCT00496158)
- Testing
- Clevudine, Adefovir
- Where
- 119 sites in United States, Argentina and 9 more
- Sponsor
- Pharmasset
Chronic Hepatitis B
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of…
- Trial name
- NCT00095121
- Testing
- Adefovir Dipivoxil (ADV), Lamivudine
- Where
- United States
- Volunteers
- 173 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past.
- Trial name
- NCT00487747
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 23 sites in Russia
- Volunteers
- 18 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B, Liver Fibrosis
MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B
How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB).
- Trial name
- NCT06779058
- Testing
- MRE, Liver biopsy
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Shengjing Hospital
Hepatitis B
Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects
The primary objective is to evaluate the safety and tolerability of single oral doses of NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) profile of NCO-48 Fumarate and its…
- Trial name
- NCT04309526
- Testing
- NCO-48 Fumarate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nucorion Pharmaceuticals, Inc.
Chronic Hepatitis B
HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated
Hepatitis B surface antigen loss/seroconversion, considered to be the ideal outcome of chronic hepatitis B virus (HBV) infection, occurs spontaneously at a low rate in inactive carriers.
- Trial name
- NCT01471535
- Testing
- Pegylated interferon alfa-2a
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Beijing Ditan Hospital
Chronic Hepatitis B
Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir
Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT05423834
- Testing
- Tenofovir alafenamide, Entecavir
- Where
- Hong Kong
- Volunteers
- 1,800 people
- Sponsor
- Chinese University of Hong Kong
Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
- Trial name
- TCR-T (NCT05417932)
- Testing
- SCG101
- Where
- 6 sites in United States, Hong Kong and 1 more
- Volunteers
- 46 people
- Sponsor
- SCG Cell Therapy Pte. Ltd.
Hepatitis B
Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B
The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.
- Trial name
- HBRN (NCT01369199)
- Testing
- Entecavir and peginterferon
- Where
- 21 sites in United States, Canada
- Volunteers
- 28 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Chronic Hepatitis B
Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to…
- Trial name
- LB80380 (NCT01242787)
- Testing
- LB80380, Entecavir 0.5 mg
- Where
- 2 sites in China, South Korea
- Volunteers
- 115 people
- Sponsor
- LG Life Sciences
HIV Infection, Hepatitis B
Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus.
- Trial name
- NCT00106964
- Testing
- Engerix-B 20 mcg, Engerix-B 40 mcg, Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg
- Where
- 11 sites in United States, Brazil and 1 more
- Volunteers
- 371 people
- Sponsor
- University of North Carolina, Chapel Hill
Hepatocellular Carcinoma
Comparison of HBV Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing ICI and Concurrent Antiviral Prophylaxis: a Prospective Observational Study
Immune checkpoint inhibitor (ICI), including programmed cell death protein-1 (PD-1) inhibitor or programmed cell death-Ligand 1 (PD-L1) inhibitor , is recommended to treat advanced hepatocellular carcinoma (HCC).
- Trial name
- NCT04680598
- Testing
- ICI, Antiviral Prophylaxis
- Where
- 4 sites in China
- Volunteers
- 800 people
- Sponsor
- Sun Yat-sen University
Chronic Hepatitis B Infection
The Changes of Cytokines 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
- NCT03210506
- Testing
- Peginterferon Alfa-2a
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Beijing Ditan Hospital
Chronic Hepatitis B, Inadequate Response
Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy
- Conditions
- Chronic Hepatitis B, Inadequate Response, Nucleos(t)Ide Analogues Treatment
- Trial name
- Dragon-Ex (NCT01829685)
- Testing
- Entecavir, Adefovir
- Where
- 16 sites in China
- Volunteers
- 360 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Chronic Hepatitis B
Adefovir and Lamivudine for Entecavir Resistance (ALTER Study)
Entecavir has been one of the option for treatment of lamivudine resistant chronic hepatitis B (CHB). In case of entecavir resistance, adefovir could be used. However, sequential monotherapy may result in multidrug resistance.
- Trial name
- ALTER (NCT01546116)
- Testing
- ADEFOVIR, LAMIVUDINE
- Where
- 9 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Korea University
Chronic HBV Infection (HBeAg Negative)
REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection
REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients and to act…
- Trial name
- NCT02233075
- Testing
- REP 2139-Ca + Pegasys (TM)
- Where
- Moldova
- Volunteers
- 12 people
- Sponsor
- Replicor Inc.
HIV Infections
Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
The purpose of this study is to find out whether these powerful combinations of anti-HIV drugs are safe and effective for use in patients in the early stages of HIV infection and to find out how patients' immune systems react to…
- Trial name
- NCT00001119
- Testing
- Tetanus Toxoid Vaccine, Indinavir sulfate, Lamivudine/Zidovudine
- Where
- 12 sites in United States, Australia
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis B, Chronic
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having…
- Trial name
- NCT00838071
- Testing
- Specific intravenous anti-hepatitis B immunoglobulin
- Where
- 4 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Instituto Grifols, S.A.
Hepatitis B, Chronic, Hepatitis D, Chronic
A Long Term Follow-up Study of Patients From the REP 301 Protocol
The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN).
- Trial name
- NCT02876419
- Where
- Moldova
- Volunteers
- 11 people
- Sponsor
- Replicor Inc.
Hepatitis B
ID HBV Vaccination With Imiquimod in OBI
During the course of chronic hepatitis B infection, patients may undergo hepatitis B surface antigen (HBsAg) seroclearance, resulting in undetectable circulating HBsAg.
- Trial name
- NCT03307902
- Testing
- Imiquimod + ID HBVv, Aqueous + ID HBVv, Imiquimod + IM HBVv
- Where
- Hong Kong
- Volunteers
- 120 people
- Sponsor
- The University of Hong Kong