Authorised Therapeutic confirmatory (Phase III) Chronic Hepatitis Delta Infection

Phase 3 Study to Evaluate Brelovitug vs Delayed Treatment for Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

EU CTIS ID: 2025-522105-38-00

What this study is testing

To evaluate the efficacy of brelovitug at Week 24 compared with delayed treatment on CHD at Week 12.

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

1. Willing and able to provide written informed consent.
2. Male or female, ≥18 years of age at Screening.
3. Confirmation of chronic HDV infection, defined as positive for anti-HDV antibody test or HDV RNA for 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.
4. HDV RNA >500 IU/mL at Screening.
5. ALT >ULN at Screening.
6. 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

1. Pregnant or nursing females.
3. 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 of acute decompensation 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 forced expiratory volume 1 second (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).
4. CTP >6 (B or C)
5. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HAV) 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 was successfully treated (HCV RNA negative) ≥6 months prior to Screening.
6. Uncontrolled human immunodeficiency virus (HIV) infection defined as having quantifiable HIV RNA levels in the blood at Screening.
7. History of hypersensitivity to any of the components in the brelovitug formulation.

See the full eligibility criteria

Who can join

1. Willing and able to provide written informed consent.
2. Male or female, ≥18 years of age at Screening.
3. Confirmation of chronic HDV infection, defined as positive for anti-HDV antibody test or HDV RNA for 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.
4. HDV RNA >500 IU/mL at Screening.
5. ALT >ULN at Screening.
6. 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.
7. In countries where HDV treatment is approved and available, participants must be documented as unwilling or unable to receive treatment.

What rules you out

1. Pregnant or nursing females.
3. 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 of acute decompensation 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 forced expiratory volume 1 second (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).
4. CTP >6 (B or C)
5. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HAV) 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 was successfully treated (HCV RNA negative) ≥6 months prior to Screening.
6. Uncontrolled human immunodeficiency virus (HIV) infection defined as having quantifiable HIV RNA levels in the blood at Screening.
7. History of hypersensitivity to any of the components in the brelovitug formulation.
8. 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 Crockcroft-Gault (CrCl) <30 mL/min d) Alpha fetoprotein (AFP) >100 ng/mL
9.Treatment with another investigational drug, a biological agent, or device within 4 weeks or 5 half-lives, whichever is longer, of Baseline.
10. Use of any interferon within 12 weeks of Screening.
11. Use of any prohibited concomitant medications as described in Study Protocol.
12. Regular alcohol misuse, defined as weekly intake of ≥14 alcoholic drinks per week (average of ≥2 alcoholic drinks per day) within 12 months of Screening.
13. Clinically relevant drug abuse (not including cannabis) within 12 months of Screening.
14. Unwillingness to comply with study procedures as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
15. 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.
2. Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study.

The study team makes the final eligibility decision.

Where it's taking place

Georgia
Israel
Pakistan
Taiwan
United States
Uzbekistan
Kazakhstan
Ukraine

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Georgia; Israel; Pakistan; Taiwan; United States; Uzbekistan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

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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.