Clinical trials: HDV
Evaluate Response to Treatment Both Biochemically and Virologically to Determine the Safety and Effectiveness of Bulevirtide Therapy in HDV Patients
Assessment of Response and Safety of Bulevirtide Treatment in Patients With Chronic Delta Virus Infection
1. The study is non-interventional, multicenter, non-profit 2. The primary objective of the study is to evaluate the safety and efficacy in clinical practice of the drug Bulevirtide in the treatment of patients with chronic HDV…
- Trial name
- ARISTOTLE (NCT07116044)
- Testing
- virological tests diagnostic tests
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- University of Molise
Chronic Delta Hepatitis
Titrating-Dose of Lonafarnib in Combination With Ritonavir
A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically infected with hepatitis delta virus (HDV)
- Trial name
- LOWR-4 (NCT02527707)
- Testing
- lonafarnib, Ritonavir
- Volunteers
- 15 people
- Sponsor
- EIT Pharma, Inc.
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
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
Type1 Diabetes Mellitus
21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus
Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study
- Trial name
- NCT03156361
- Testing
- HDV insulin lispro 100 UNIT/mL, Insulin Lispro 100 Units/mL
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Diasome Pharmaceuticals
Chronic Hepatitis D Infection
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.
- Trial name
- NCT07298330
- Testing
- Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg
- Where
- 27 sites in United States, Belgium and 8 more
- Volunteers
- 80 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis D
Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China
This is a retrospective, prospective, noninterventive, multicenter registry study. Patients diagnosed with HDV infection (based on positive HDV RNA) were included in this study and were followed up for at least 5 years to…
- Trial name
- NCT05451082
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Lai Wei
Hepatitis D
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Retrospective and prospective, pharmacological, multicentre, non-profit observational study. Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be…
- Trial name
- SAVE-D (NCT06397859)
- Testing
- Bulevirtide
- Where
- Italy
- Volunteers
- 266 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Hepatitis Delta Virus, Hepatitis D
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants
This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. Effect of food will also be evaluated in Part A.
- Trial name
- NCT06740474
- Testing
- ABI-6250
- Where
- New Zealand
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Chronic Hepatitis D Infection
A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.
- Trial name
- NCT07499544
- Testing
- Libevitug 20 mg/kg, Libevitug 10 mg/kg, Delayed treatment with libevitug
- Where
- 7 sites in United States, China and 1 more
- Volunteers
- 160 people
- Sponsor
- Huahui Health
Type 1 Diabetes
Suppression of Endogenous Glucose Production by Injectable HDV-Insulin Lispro: A Dose Response Study in Human Subjects With Type 1 Diabetes
Single-center, double-blind, random-sequence study assessing the HDV dose-response relationship to Endogenous Glucose Production (EGP), Free Fatty Acids (FFA) and Glucose Disposal Rate (GDR) during a euglycemic clamp procedure…
- Trial name
- NCT05689424
- Testing
- HDV-Insulin Lispro
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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
Chronic Hepatitis C
HDV-Interferon in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients
A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results in similar efficacy [Rapid Virologic…
- Trial name
- NCT00703872
- Testing
- Oral HDV-Interferon + ribavarin, Injectable HDV-Interferon + ribavarin
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Hepasome Pharmaceuticals
Hepatitis D
The Hepatitis Delta International Network
Hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment.
- Trial name
- HDIN (NCT02375906)
- Where
- 18 sites in Austria, Belgium and 10 more
- Volunteers
- 2,000 people
- Sponsor
- HepNet Study House, German Liverfoundation
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
Hepatitis D
Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy
Spontaneous, pharmacological observational, no-profit, retrospective, multi-center. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers.
- Trial name
- HEP4Di (NCT05962307)
- Testing
- Bulevirtide
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus
A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
- Trial name
- NCT00521378
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Diasome Pharmaceuticals
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 Hepatitis D Infection
Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)
An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib with Ritonavir Boosting +/- Peginterferon alfa-2a in Patients Chronically Infected with Delta Hepatitis (HDV) (LOWR-2).
- Trial name
- LOWR-2 (NCT02430194)
- Testing
- lonafarnib, ritonavir, Pegylated interferon-alfa-2a
- Where
- Turkey (Türkiye)
- Volunteers
- 55 people
- Sponsor
- EIT Pharma, Inc.