Clinical trials: HBV/HDV
HIV Infection, HBV Infection
"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort"
The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health.
- Conditions
- HIV Infection, HBV Infection, HDV Infection, HCV Infection
- Trial name
- VIROPREG (NCT07412977)
- Testing
- Blood sampling, Umbilical cord blood sampling, Survey using a questionnaire
- Where
- France
- Volunteers
- 5,160 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Hepatitis D Virus Infection
HDV Screening Study
This is a territory-wide cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC.
- Trial name
- NCT06889805
- Where
- Hong Kong
- Volunteers
- 300 people
- Sponsor
- Grace Lai Hung Wong
HDV
Thailand HDV Cohort
There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special…
- Trial name
- NCT05350865
- Where
- 4 sites in Thailand
- Volunteers
- 3,296 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
HBV, HCV
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.
- Conditions
- HBV, HCV, HDV, Coinfection
- Trial name
- HEAL-S (NCT06834178)
- Where
- Austria
- Volunteers
- 100 people
- Sponsor
- Vanessa Stadlbauer-Koellner, MD
Chronic Hepatitis Delta, Liver Biopsy
Study the Content of the HBV DNA in Liver Biopsy in the Patients Chronic Hepatitis Delta
Study the content of the HBV DNA in liver biopsy in the patients with the Chronic Hepatitis Delta in absence of the HBV DNA in the blood plasma
- Trial name
- NCT04170452
- Testing
- liver biopsy
- Where
- Uzbekistan
- Volunteers
- 30 people
- Sponsor
- Tokhirbek Dolimov
Chronic Viral Hepatitis B Without Delta-agent
Telbivudine Versus Entecavir in Reducing Serum HBsAg Levels in Patients With HBeAg-positive Chronic Hepatitis B
The goal of chronic hepatitis B (CHB) treatment is complete and permanent eradication of hepatitis B virus (HBV) from patient's body, which is best represented by serum HBsAg loss accompanied by undetectable serum HBV DNA level.
- Trial name
- TERESA (NCT01595685)
- Testing
- Telbivudine, Entecavir
- Where
- South Korea
- Volunteers
- 98 people
- Sponsor
- Asan Medical Center
HEPATITIS C (HCV), Hepatitis B Virus (HBV)
Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France
In Mongolia, mortality from hepatocellular carcinoma (HCC) is one of the highest in the world. Viral hepatitis is the main cause of HCC: the prevalence of hepatitis B (HBV) estimated at 11% In Mongolia, hepatitis C (HCV) at 8.5%…
- Conditions
- HEPATITIS C (HCV), Hepatitis B Virus (HBV), Hepatitis D, Hepatocellular Carcinoma (HCC)
- Trial name
- Mondelta (NCT07038863)
- Testing
- Community screening for hepatitis B, C and delta in the Mongolian population living in France
- Where
- 11 sites in France
- Volunteers
- 2,000 people
- Sponsor
- Hospices Civils de Lyon
Hepatitis B, Chronic, Hepatitis D
A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection
This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in both volunteers with chronic hepatitis B virus infection and in volunteers with hepatitis D virus coinfection.
- Trial name
- NCT04847440
- Testing
- ATI-2173, Viread, AB-729
- Where
- 2 sites in Moldova, Ukraine
- Volunteers
- 40 people
- Sponsor
- Antios Therapeutics, Inc
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
Hepatitis D, Chronic
Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection
Open label, single arm, multi-center clinical trial of lonafarnib 50 mg QD plus ritonavir 200 mg QD, administered orally, over a 48-week treatment period, with a 24-week post-treatment follow-up period, in patients with chronic…
- Trial name
- LOWR6 (NCT05229991)
- Testing
- Lonafarnib, Ritonavir
- Where
- 3 sites in Israel, New Zealand and 1 more
- Volunteers
- 10 people
- Sponsor
- Soroka University Medical Center
Hepatitis D
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
Pharmacological, single-center, non-profit observational study. The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan…
- Trial name
- MPR_BD (NCT06504485)
- Testing
- Bulevirtide
- Where
- Italy
- Volunteers
- 192 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Hepatitis D, Chronic, Hepatitis B, Chronic
National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.
- Trial name
- HEPDELTA (NCT04166266)
- Testing
- Blood draw for the laboratory assessment
- Where
- 38 sites in France
- Volunteers
- 800 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Chronic Viral Hepatitis B Without Delta-agent
Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant Chronic Hepatitis B
With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by polymerase chain reaction (PCR) assays became…
- Trial name
- IN-US-0202 (NCT01639092)
- Testing
- Tenofovir, Entecavir
- Where
- South Korea
- Volunteers
- 88 people
- Sponsor
- Asan Medical Center
Hepatitis D
HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection
The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for…
- Trial name
- NCT06264583
- Testing
- HDV screening
- Where
- Germany
- Volunteers
- 8,000 people
- Sponsor
- University Hospital, Bonn
HBV, HBV Coinfection
Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%.
- Conditions
- HBV, HBV Coinfection, HCV, HIV Infections
- Trial name
- Bio-Delta (NCT07429864)
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Chronic Viral Hepatitis B Without Delta-agent
Tenofovir Plus Entecavir vs. Tenofovir in Adefovir-Resistant Chronic Hepatitis B
With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by polymerase chain reaction (PCR) assays became…
- Trial name
- IN-US-0205 (NCT01639066)
- Testing
- Tenofovir, Entecavir
- Where
- South Korea
- Volunteers
- 102 people
- Sponsor
- Asan Medical Center
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
Chronic Hepatitis B Infection
Hepatitis B Infection Surveillance
France is a low-endemicity country for hepatitis B virus (HBV) infection. In 2016, the prevalence of chronic HBV infection in the general population was estimated at 0.3%, corresponding to more than 135,000 HBsAg-positive…
- Trial name
- HEPB-SURVEY (NCT07727187)
- Where
- France
- Volunteers
- 1,360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
HBV, HBV/HDV
Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease
Prospective, non-pharmacological, single-center, non-profit observational study. The study design allows longitudinal evaluation of the immune response during the natural history of the infection and/or treatment, correlating the…
- Trial name
- BDTc (NCT06372990)
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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.