Clinical Trials for Hepatitis A

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Hepatitis A from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 14
• Active, not recruiting: 11
• Completed: 18
• Other: 7

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT00001971 — Evaluation of Patients With Liver Disease

The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver.

Patients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the …

NCT05403047 — Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women

Pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate (TDF) from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation.

The investigators hypothesise that a…

NCT07573943 — ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection

Exploring the safety and efficacy of the therapy combining immune checkpoint inhibitors (anti-PD-L1 monoclonal antibody, ASC22) and pegylated interferon alfa (Peg-IFNα) in patients with CHB. Exploring new combination therapeutic schemes for hepatitis B cure, and raising the overall clinical cure rate to more than 50% without screening specific advantageous groups.

NCT06638320 — Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection

The goal of this observational study is to determine the prevalence of hepatitis D virus (HDV) and the distribution of the HDV genotype in patients with chronic hepatitis B infection. It will also identify factors related to hepatitis D virus infection, such as characteristics of the study sample, vaccination history, drug use affecting hepatitis, family factors, environment, and lifestyle.

Th…

NCT07024641 — A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.

NCT06864481 — Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

Background and Study Rationale Immune checkpoint inhibitors (ICI) are a breakthrough cancer treatment that boosts the immune system to fight tumors. While effective, they can cause immune-related side effects, including liver inflammation (ICI-induced hepatitis or CHILI), which affects up to 25% of patients. Severe cases requiring treatment discontinuation are rare but challenging to manage.

S…

NCT06834178 — Non-interventional Study to Assess the Number of People With Untreated/Unknown HBV + HDV and HCV in South-East Austria

The HEAL-S study is a non-interventional study with retrospective data analysis. It consists of two parts. First a retrospective analysis based on nucleic acid testing (NAT) results will be performed. Two cohorts (HCV) and (HBV) will be established. Patients falling into one (or both) of the two cohorts will be invited to a prospective linkage-to-care study. In this part, patients are invited t…

NCT07060638 — Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial

This is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD).

The primary purpose of the study is to determine whether subjects receiving sAH therapy in addition to AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to sAH therapy plus usual c…

NCT07389044 — 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, and will be conducted in two parts:

Part A: SAD study in approximately 50 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).

NCT07454837 — Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

NCT07667101 — Hepatitis C Pharmacist, Physician, Patient Navigator Collaborative Care Model in Permanent Supportive Housing

The objective of this study is to extend our prior research by conducting a pragmatic implementation trial using a parallel-group, cluster randomized design to evaluate the PPP-CCM’s ability to improve access to DAAs for HCV within a network of permanent supportive housing (PSH) buildings in Seattle and King County. The study will implement PPP-CCM to 16 housing buildings, randomizing half to r…

NCT06843148 — Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.

Metabolic dysfunction-associated steatotic liver disease (MASLD) (aka non-alcoholic fatty liver disease), commonly occurring in individuals with obesity and type 2 diabetes can lead to liver inflammation/ fibrosis. MASLD results from fat being disproportionately deposited in the liver.

The goal of this mechanistic study is to investigate metabolic response in patients aged 20 to 80 years with …

NCT07040319 — Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV

This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.

NCT07051187 — A Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection

Existing nucleoside analogues (NAs) and interferon therapy for chronic hepatitis B (CHB) have limitations, including drug resistance, low HBsAg clearance rates, and irreversible immunosuppression. Therapeutic vaccines, by activating virus-specific T cells and B cells, hold promise for achieving functional cure (HBsAg clearance + sustained HBV DNA negativity). This study is an open-label, single…

Active, Not Recruiting

NCT02995252 — The HOPE Study: Characterizing Patients With Hepatitis B and C

This is an observational, longitudinal, prospective study for sample collection and evaluation for future therapy or disease progression of chronic hepatitis B and C. Participants will be seen on an annual basis with optional additional visits for up to 10 years and provide samples for research and evaluation of disease progression. In addition, there is a longitudinal sub-study for treatment o…

NCT02932150 — Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.

NCT03520660 — People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

Background:

Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why.

Objective:

To study the course and complications of liver disease after cure of hepatitis C infection.

Elig…

NCT03761875 — NK Cell Deregulation in HBV Patients

Natural Killer (NK) cells play a large role in the innate immune response as they are equipped to kill infected or tumor cells. They express a panel of activating and inhibitory receptors that regulate the destruction of the target cell. Many reports have shown that NK cell function is suppressed in CHB patients. Exhaustion occurs when activating receptors become over stimulated leading to the …

NCT04704024 — Reducing Vertical Transmission of Hepatitis B in Africa

Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral me…

NCT04954859 — Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)

This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent…

NCT05461170 — SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy

NCT06497504 — Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)

This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.

NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy. The study also aims to identify an optimal dose of DAP/TOM for sequenced therapy with bepirovirsen for further clinical development and to assess the contribution of DAP/TOM to the sequential r…

NCT07037277 — C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

NCT07298330 — A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.

Not Yet Recruiting

NCT07673068 — 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. The study is designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of TVAX-028 in patients with chronic hepatitis B virus infection

NCT07663422 — Mycophenolate Mofetil w/ Prednisone for Immune Related Hepatitis From Checkpoint Inhibitor Therapy

This phase II study evaluates whether early treatment with mycophenolate mofetil (MMF) plus prednisone improves liver inflammation caused by immune checkpoint inhibitors. The study includes patients who develop moderate to severe immune-related hepatitis after receiving PD-(L)1 or CTLA-4-based cancer therapy. The main goal is to determine how many patients experience improvement in liver functi…

NCT07647978 — Development of a Predictive Score for the Risk of Infection in the Immediate Post-liver-transplant Period

Liver transplantation (LT) is the only curative treatment option for patients with severe liver disease. Since 2007, the implementation of the MELD score in liver transplant allocation guidelines has led to a change in the profile of transplant recipients, notably with an increase in the proportion of patients receiving transplants for severe liver failure. Thus, in 2023, nearly 40% of liver tr…

NCT07684209 — A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV Nucleic Acid

The research plan aims to evaluate the consistency of the digital PCR-based hepatitis B virus nucleic acid quantification technique with the existing Roche qPCR-based detection method. Approximately 200 samples of residual serum from patients with chronic hepatitis B, covering high, medium, low, and those below the Roche lower limit concentration or undetectable, will be collected. The two meth…

NCT07658976 — Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy

Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men

NCT07378761 — Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis

The clinical trial aims to compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period.

The trial presents a detailed scientific justification for comparing UDCA to corticosteroids, describing the treatment and detailing the follow-up procedures. It hypothesizes that UDCA could…

Enrolling by Invitation

NCT07668934 — TAF in Early/Middle Pregnancy With CHB

The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.

Completed Trials

NCT00004850 — Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection

This study will evaluate hepatitis C virus (HCV) infection in blood donors who test positive for antibodies to this virus. Most HCV-infected people do not become ill and are not aware that they have hepatitis or have had it in the past. Some infected people recover completely, whereas others remain chronically infected. The study will try to define infectivity of anti-HCV positive individuals, …

NCT00023023 — Study of Transfusion-Transmitted Infections

This study will follow blood transfusion recipients for 6 to 9 months following transfusion to monitor the quality and safety of blood transfusion. Improved viral testing and careful donor screening in the last several years has dramatically reduced the rates of transfusion-related HIV and hepatitis. Nevertheless, ongoing surveillance of transfusion-related infections is essential to maintain a…

NCT01581554 — Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B

Background:

- Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and cancer of the liver. There is no cure for the infection, but several drugs have been approved to treat it. These drugs can keep the virus levels low. They seem to be safe for short-term use. But the drugs have not yet been approved for long-term use because some of them can have serious side e…

NCT07687758 — Non-Invasive Risk Stratification for Hepatocellular Carcinoma in HCV-Related Compensated Advanced Chronic Liver Disease Following Sustained Virological Response: Validation of the aMAP Score

This retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy. Patients treated at Siriraj Hospital between 2013 and 2023 were included if the…

NCT07671508 — Prophylaxis of Complications of Basic Therapy Using Naderin in Socially Significant Diseases

This interventional study evaluated the efficacy of Naderin (sodium nucleinate) for the prophylaxis of complications during basic therapy and medical rehabilitation in patients with socially significant diseases, including malignant neoplasms, tuberculosis, and hepatitis C. The study assessed the immunocorrective effects of Naderin on hematological parameters, the incidence of infectious compli…

NCT02190253 — Seroprevalence of Hepatitis E in People With an Organ Transplant

Background:

- The hepatitis E virus causes an acute hepatitis that usually goes away by itself. Researchers in France studied people who received a liver or kidney transplant. They found that hepatitis E may not go away by itself in these people. It becomes chronic. This can cause serious liver disease. More than half the people who had organ transplant who had hepatitis E seemed to get a chr…

NCT02344680 — Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

A cohort of adults with HIV-HBV co-infection will be created in Lusaka, Zambia, to describe the short and long-term (up to 10 years of follow-up) HBV and liver outcomes, including the effectiveness of current therapies, and to identify the risk factors for major endpoints of interest, including HCC and HBV functional cure. This cohort will also create a pool of potential participants for in-dep…

NCT03222531 — Expanding the Pool in Orthotopic Heart Transplantation

This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm…

NCT03601546 — Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam

The purpose of this study is to evaluate the feasibility of implementing a cohort of patients with Hepatitis C in order to generate a larger cohort for future studies

NCT04294498 — Durvalumab for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection

PD1 blockade has been approved as salvage therapy for advanced hepatocellular carcinoma (HCC). Although there is not solid evidence that PD1 blockade would induce hepatitis B virus (HBV) reactivation, previous clinical trials of PD1 blockade required enrolled patients to receive anti-HBV medications and control the viral load to be under 100-2000 IU/mL before initiation of PD1 blockade therapy….

NCT05532345 — Discrimination of DILI and AIH by Artificial Intelligence

A retrospective, multi-center, non-interventional cohort study has been going to explore whether artificial intelligence can discriminate Drug-induced liver injury and Autoimmune hepatitis.

A machine learning-based tool will be developed and validated to help clinicians to differentiate between Drug-induced liver injury and Autoimmune hepatitis

NCT05397067 — Linkage to Care for Persons With Hep C Infection

Hepatitis C Virus (HCV) infection is an ongoing challenge in the United States, with an estimated 2.4 million individuals living with HCV in 2016. According to the Virginia Department of Health, over 11,500 people were living with HCV infection in 2017 with a rate of 170 reported cases/100,000 adults. This study evaluated community-based interventions to improve linkage to care (LTC) among indi…

NCT05208697 — Tele-Harm Reduction

The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.

NCT05630820 — Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for …

NCT05630807 — Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for …

NCT06413121 — 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 the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries…

NCT06263829 — HCV Tappt Adherence Study

The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.

• The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion,…

NCT07595159 — A Study of BW-20507 in Chinese Healthy Subjects and Subjects With Chronic Hepatitis B

Phase 1 Study of BW-20507 in Healthy Subjects and Patients With Chronic Hepatitis B. Ia involved a single ascending dose study where healthy participants were administered one dose of BW-20507 or placebo subcutaneously. Ib involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered with multiple doses of BW-20507 SC