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Compares treatment options for Chronic Hepatitis D Infection
Official title A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
ClinicalTrials.gov ID: NCT07200908
What this study is testing
What is Brelovitug 300 mg?
Brelovitug 300 mg is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for chronic hepatitis d infection.
Also referred to as BJT-778, BTG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Willing and able to provide written informed consent
- Chronic HDV infection
- HDV RNA \>500 IU/mL at Screening
- ALT \>ULN at Screening
- Willing to take or already taking HBV neucleos(t)ide therapy. Key
You likely can't join if
- Pregnant or nursing females
- Unwilling to comply with contraception requirements during the study
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- Solid organ or bone marrow transplantation
- Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver...
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Sankt Pölten, Austria
- Brno, Brno, Czechia
- Hradec Králové, Hradec Králové, Czechia
- Liberec, Liberec, Czechia
- Prague, Prague, Czechia
- Clermont-Ferrand, France
- Clichy, France
- Créteil, France
- La Tronche, France
- Le Chesnay, France
- Lille, France
- Limoges, France
- Lyon, France
- Paris, France
- Pessac, France
- Rennes, France
- Toulouse, France
- Frankfurt, Frankfurt, Germany
- Rostock, Rostock, Germany
+ 25 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Sankt Pölten, Austria; Brno, Brno, Czechia; Hradec Králové, Hradec Králové, Czechia; Liberec, Liberec, Czechia; Prague, Prague, Czechia and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.