Clinical Trials for Hepatitis E

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 E from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 5
• Active, not recruiting: 0
• Completed: 26
• Other: 19

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

Recruiting Trials

NCT05182463 — Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, result…

NCT06306196 — Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children

The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) o…

NCT05808166 — Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women

This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity subset (n=150), Arm 2, pregnant participants receiving placebo (N=1,104) with immunogenicity subset (n=150), and Arm 3, non-pregnant participants receiving Hecolin® (N…

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective

RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.

RACSMEI will improve understanding across multiple pathogens using a multidisciplinary One He…

NCT07370207 — Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs).

Not Yet Recruiting

NCT06859619 — Serological Measurement of Montpellier Professionals’ Contacts with Infectious Agents Responsible for Animal-borne Diseases

Zoonoses and arboviroses refer to a group of diseases transmitted from animals to humans, either directly or indirectly (via mosquitoes, ticks or contact with contaminated environments). Most of these diseases are found in certain tropical zones, but global warming and increased international trade are modifying their geographical distribution, with a gradual trend towards temperate regions. A …

NCT07525401 — Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis

Hepatitis is an inflammatory condition of the liver that has emerged as a significant global health concern due to its widespread prevalence.

Data on ursodeoxycholic acid in acute viral hepatitis remain limited. Some studies suggest its positive effect in cholestatic phase of viral hepatitis. UDCA may reduce cholestatic symptoms like jaundice and pruritus potentially shortening hospital stay a…

NCT07654283 — Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with CHB treated with Nucleos(t)ide Analogue (NAs).

Completed Trials

NCT00034359 — Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection

The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.

NCT01014845 — Clinical Trial of Recombinant Hepatitis E Vaccine

The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine.

The secondary purpose of this study is to to evaluate the safety and immunogenicity and immunopersistence of the study vaccine.

The initial study is planed to be ended on month 19 a…

NCT04670419 — Morbidity and Mortality of Hepatitis E Virus Infections in Belgium

Hepatitis E Virus (HEV) infections are emerging in the Western world with a predominance of HEV genotype (gt) 3. Except for age older than 50 years, male gender, chronic liver disease and immunosuppressed status, no correlators with clinical outcomes have been identified so far. With this study, we want to examine viral factors associated with the morbidity and mortality of HEV infections in Be…

NCT01034254 — Field Trial of Maternal Influenza Immunization in Asia

This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number of large scale randomized trials ha…

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…

NCT01745822 — Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand

Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma, even if her infant receive specific immunoglobulin and vaccine.

The hypothesis of this study is that a potent antiviral, tenofovir,…

NCT01940471 — Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen

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 B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

NCT01940341 — Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen

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 B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.

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…

NCT02836249 — 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 B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection in China.

NCT02836236 — Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative 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 B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection in China.

NCT02594293 — Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy

This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal.

The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010) were randomly assigned into three groups: One group discontinue …

NCT02645955 — Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients

Primary Purpose:

1. Evaluate the prevalence and incidence of HEV infection in MHD patients.
2. Compare differences of the prevalence and incidence between the MHD patients and the control. .

Secondary purpose:

Analyze risk factors of HEV infection.

NCT02759991 — Effectiveness Trial to Evaluate Protection of Pregnant Women by Hepatitis E Vaccine in Bangladesh.

The aim of the study is to determine the effectiveness of hepatitis E virus vaccine given in women of child bearing age in preventing HEV disease during pregnancy among women in rural Bangladesh.

NCT03365921 — A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Lot Consistency Trial)

This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.

NCT03827395 — Safety Study of Hepatitis E Vaccine (HEV239)

This is a Phase I double-blind, randomized, placebo controlled trial (1:4 ratio of placebo to vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R) (HEV-239) in 25 US males and non-pregnant females ages 18 - 45 (inclusive) to assess the safety, reactogenicity, and immunogenicity of HEV-239. Subjects will receive 3 doses of study product on Days 1, 29, and 1…

NCT04904835 — Access HBV Assays - European Union (EU) Clinical Trial Protocol -

The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.

The study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Hepatitis B Virus assays as required per the Euro…

NCT04129554 — A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

NCT06631560 — Hepatitis E Virus Infection in Oncological Patients

The goal of this clinical trial is to investigate the prevalence of hepatitis E infection in oncological patients in a rural region of Germany. Consequently, we conducted prospective testing of blood samples from patients with haematological malignancies for evidence of HEV infection using two distinct anti-HEV IgG and IgM enzyme-linked immunosorbent assays (ELISAs). Serum was taken from each p…

NCT04439539 — A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection

The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).

NCT05123599 — A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels.

NCT05300425 — Seroprevalence of Leptospirosis in Val Müstair, Switzerland

Human leptospirosis is a zoonotic disease caused by bacteria of the genus Leptospira. Due to its frequent inapparent course or mild severity with unspecific symptoms and limited availability of diagnostic laboratories the incidence of leptospirosis is likely to be underestimated. The hospital of Val Müstair is the major healthcare provider of a rural mountain valley in the canton of Graubünden/…

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 …

NCT06564116 — Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli) when administered in participants ages 16 years and above.

NCT06744686 — Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients with Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity (only in Participants with Chronic HBV Infection)

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study

Other (Terminated)

NCT00040144 — Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B

The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.

NCT00755950 — Randomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis

The purpose of this study is to assess whether two higher doses (280mg or 420mg three times daily)of silymarin therapy are safe and tolerable, and shorten the illness in patients with acute viral hepatitis compared to placebo.

NCT02452528 — Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus

Participants with chronic HBV infection will receive multiple doses of ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.

NCT02604199 — A Multi-dose Study of ARC-520 in Patients With Hepatitis B ’e’ Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection

Patients with chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.

NCT02604212 — A Multi-dose Study of ARC-520 in Patients With Hepatitis B ’e’ Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection

Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.

Other (Unknown)

NCT02845401 — The Hepatitis B e-Antigen Negative Disease - Directly Offered Study of Treatment Withdrawal in Patients With e-Antigen Negative Chronic HBV Infection (BeNEG-DO).

The investigators’ research is aimed at developing more effective, finite approaches for managing individual patients with chronic hepatitis B (CHB). This prospective clinical and basic scientific study exclusively focuses on patients with the early antigen negative form of disease, which in developed countries is treated indefinitely with antiviral drugs. The investigators’ study “BeNEG-DO,” d…

NCT03780543 — A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients

Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.

NCT04023721 — Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor

An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B e antigen (HBeAg)-negative subjects with chronic HBV infection.

Other (Withdrawn)

NCT05867056 — 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). This is the first in-human study of IMC-I109V in persons with CHB.

NCT04805034 — Predictive Model for Prognosis of Chronic HBV Infection Mothers

Pregnancy is a complex and coordinated physiological process. Pregnancy and the postpartum period are associated with unique changes in the immune system that may impact the natural history of autoimmune diseases and immune-mediated infections. In the postpartum period. ALT flares have been reported in 20%-60% of untreated women and were more likely to occur in hepatitis B e antigen (HBeAg)-posi…

NCT05415345 — Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin

The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)

NCT06457438 — Molecular Characteristics and Prevalence of Viral Hepatitis E in Human Tissue and Cell Donors

In this study, the researchers want to focus on the prevalence of anti-HEV antibodies by a new generation test, direct detection of HEV RNA, and its genotypic analysis in a group of human tissue and cell donors.

NCT05550519 — 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 to (<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (>) 100 IU/mL to <= 500 IU/mL at baseline.

NCT05614466 — The SIMPLY-B Study

This study will be conducted in three parts:

Part A: A prospective open label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care settings before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package.

Part B: A nested qualitative health services feasibility study using semi -st…

NCT05976594 — Long-term Effectiveness of a Recombinant Hepatitis E Vaccine

This test-negative study is designed to evaluate the long-term effectiveness of hepatitis E vaccine (Hecolin®) and to explore the prevalence of rat hepatitis E in Dongtai City.

NCT06137313 — Exposure to Hepatitis E Virus in Occitania, France

The objective of the proposed work is to determine the seroprevalence of HEV in 2023 in a population of blood donors living in Occitania.

Compare the current frequency of anti-HEV IgG and IgM markers with that of 2011. The serological techniques used and the questionnaires will be similar