Clinical trials: Chronic Hepatitis Delta Virus Infection
Hepatitis D, Chronic
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.
- Trial name
- LIMT (NCT02765802)
- Testing
- Peginterferon Lambda-1A
- Where
- 4 sites in Israel, New Zealand and 1 more
- Volunteers
- 33 people
- Sponsor
- EIT Pharma, Inc.
Hepatitis B, Chronic
Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection
This study was designed for changes in endotoxaemia, endotoxin-binding factors, sICAM-1 (soluble intracellular adhesion molecule-1), and cytokines during progression of chronic HBV infection.
- Trial name
- OCEHBV (NCT01107483)
- Where
- China
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
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.
Viral Hepatitis
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
- Trial name
- NCT07128550
- Testing
- Tobevibart, Elebsiran, Bulevirtide
- Where
- 38 sites in Austria, France and 5 more
- Volunteers
- 150 people
- Sponsor
- Vir Biotechnology, Inc.
Chronic Hepatitis D Infection
A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function
The goals of this study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the…
- Trial name
- NCT05760300
- Testing
- Bulevirtide (BLV)
- Where
- 9 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Viral Hepatitis
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
- Trial name
- NCT06903338
- Testing
- Tobevibart, Elebsiran
- Where
- 39 sites in United States, Canada and 8 more
- Volunteers
- 124 people
- Sponsor
- Vir Biotechnology, Inc.
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
Hepatitis D, Chronic, Hepatitis B Chronic Infection
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection
Hepatitis D virus (HDV) is a major global health issue, with an estimated 12 million people living with the infection worldwide.
- Trial name
- NCT07610772
- Testing
- HepB mAb19
- Where
- 2 sites in Denmark, Germany
- Volunteers
- 15 people
- Sponsor
- Aarhus University Hospital
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, Chronic
A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D.
- Trial name
- NCT01088659
- Testing
- peginterferon alfa-2a [Pegasys], tenofovir
- Where
- 6 sites in Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis D Infection
A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD).
- Trial name
- NCT07200908
- Testing
- Brelovitug 300 mg, Bulevirtide 2 mg and Brelovitug - 300 mg
- Where
- 57 sites in Austria, Czechia and 10 more
- Volunteers
- 172 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Chronic Hepatitis D
Burden of Hepatitis D Virus (HDV) Infection in Italy
The circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced…
- Trial name
- HDV Describe (NCT05723068)
- Where
- 36 sites in Italy
- Volunteers
- 515 people
- Sponsor
- University of Turin, Italy
Chronic Delta Hepatitis
A Study of Lonafarnib With or Without Ritonavir in Patients With HDV
A Phase 2b, Open-Label, Randomized Study of the Safety, Tolerability, and Pharmacodynamic Activity of Lonafarnib With or Without Ritonavir in Patients Chronically Infected with Hepatitis Delta Virus
- Trial name
- LOWR-5 (NCT02968641)
- Testing
- Lonafarnib, Ritonavir
- Sponsor
- Eiger BioPharmaceuticals
Chronic Hepatitis Delta
Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)
The primary objective of this study is to evaluate the efficacy of bulevirtide administered subcutaneously (SC) for 48 weeks at a dose of 2 mg or 10 mg once daily for treatment of chronic hepatitis delta (CHD) in comparison to…
- Trial name
- NCT03852719
- Testing
- Bulevirtide
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 150 people
- Sponsor
- Gilead Sciences
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
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Multicenter pharmacological observational prospective, no-profit, study. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers.
- Trial name
- D-SHIELD (NCT06122285)
- Testing
- Bulevirtide
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Chronic Hepatitis B
Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF
In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF).
- Trial name
- SWITAF (NCT03356834)
- Testing
- Tenofovir alafenamide(TAF), Tenofovir disoproxil fumarate(TDF)
- Where
- Hong Kong
- Volunteers
- 575 people
- Sponsor
- Humanity and Health Research Centre
Chronic Hepatitis Delta
Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)
The primary objective of this study is to evaluate the efficacy of bulevirtide in combination with pegylated interferon in participants with chronic hepatitis delta (CHD).
- Trial name
- NCT03852433
- Testing
- Bulevirtide, Peginterferon Alfa-2a (PEG-IFN alfa)
- Where
- 20 sites in France, Moldova and 2 more
- Volunteers
- 175 people
- Sponsor
- Gilead Sciences
Hepatitis D, Chronic
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
- Trial name
- NCT05461170
- Testing
- VIR-2218, VIR-3434, NRTI
- Where
- 20 sites in Bulgaria, France and 7 more
- Volunteers
- 95 people
- Sponsor
- Vir Biotechnology, Inc.