BridgeMD
A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
EU CTIS ID: 2024-517167-23-00
What this study is testing
To evaluate the efficacy of brelovitug compared with bulevirtide treatment of CHD at Week 48
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Willing and able to provide written informed consent
- Male or female, ≥18 years of age at Screening
- Confirmation of chronic HDV infection, defined as a positive for anti-HDV antibody test or HDV RNA at least 6 months prior to Day 1. If prior documentation is not available, then HDV RNA positivity along with evidence of fibrosis (liver stiffness of ≥7 kPa) is acceptable.
- HDV RNA >500 IU/mL at Screening
- ALT >ULN at Screening
- Taking or willing to take tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or entecavir (ETV) at baseline, and willing to remain on stable treatment for the duration of the study.
You likely can't join if
- Pregnant or nursing females
- Received bulevirtide at any time prior to Screening, or unwilling or unable to receive bulevirtide treatment.
- Unwilling or unable to self-inject study medication, including daily injection with bulevirtide
- Use of any prohibited concomitant medications, including any interferon within 12 weeks prior to Screening, as described in Section 7.8, or described in the Hepcludex SmPC/Product Information
- Regular alcohol misuse, defined as weekly intake of ≥14 drinks per week (average of ≥2 drinks per day) within 12 months of Screening
- Clinically relevant drug abuse (excluding cannabis) within 12 months of Screening
See the full eligibility criteria
Who can join
- Willing and able to provide written informed consent
- Male or female, ≥18 years of age at Screening
- Confirmation of chronic HDV infection, defined as a positive for anti-HDV antibody test or HDV RNA at least 6 months prior to Day 1. If prior documentation is not available, then HDV RNA positivity along with evidence of fibrosis (liver stiffness of ≥7 kPa) is acceptable.
- HDV RNA >500 IU/mL at Screening
- ALT >ULN at Screening
- Taking or willing to take tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or entecavir (ETV) at baseline, and willing to remain on stable treatment for the duration of the study.
What rules you out
- Pregnant or nursing females
- Received bulevirtide at any time prior to Screening, or unwilling or unable to receive bulevirtide treatment.
- Unwilling or unable to self-inject study medication, including daily injection with bulevirtide
- Use of any prohibited concomitant medications, including any interferon within 12 weeks prior to Screening, as described in Section 7.8, or described in the Hepcludex SmPC/Product Information
- Regular alcohol misuse, defined as weekly intake of ≥14 drinks per week (average of ≥2 drinks per day) within 12 months of Screening
- Clinically relevant drug abuse (excluding cannabis) within 12 months of Screening
- Unwillingness to comply with study procedures as specified by this protocol, or unwillingness to cooperate fully with the Investigator
- Have any other conditions (medical, social, psychiatric, or other), which in the opinion of the Investigator would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study
- Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study
- Current, prior history, or is under evaluation for any of the following: a) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy b) Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). Incidental small ascites on imaging without other clinical symptoms/signs would not exclude the participants. c) Hepatocellular carcinoma; suspected HCC on ultrasound at Screening d) Vasculitis e) Extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa) f) Solid organ or bone marrow transplantation g) Significant pulmonary disease (e.g., O2-dependent or FEV1 ≤50% predicted value) h) Significant cardiac disease (e.g., history of myocardial infarctions within 6 months, any history of ventricular tachycardia, congestive heart failure, dilated cardiomyopathy with left ventricular ejection fraction <40%) i) Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to Screening).
- CTP >6 (Class B or C) (see Section 6.7.7.2)
- Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or hepatitis A virus) or non-viral hepatitis that has the potential to impact interpretation of data. Exceptions to this criterion include fatty liver without any signs of steatohepatitis or past HCV infection that has resolved or been successfully treated (HCV RNA negative ≥6 months) prior to Screening.
- Uncontrolled HIV infection defined as having quantifiable HIV RNA levels in the blood at Screening
- History of hypersensitivity to any of the components in the brelovitug or bulevirtide formulation
- Screening laboratory results as follows, or any other clinically significant abnormalities in Screening laboratory values that would render a participant unsuitable for inclusion: a) Platelet count <50,000/mm3 b) Hemoglobin <10.0 g/dL c) Creatinine clearance by Cockcroft-Gault (CLCr) <50 mL/min d) Alpha fetoprotein >100 ng/mL
- Treatment with an investigational drug, a biological agent, or device within 4 weeks of baseline or 5 half-lives, whichever is longer
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Switzerland. 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 EU CTIS; the study team decides eligibility.