Brelovitug for Hepatitis D

Recruiting at 54 trial locations

Overseen By Bluejay Clinical Trials Information

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Bluejay Therapeutics, Inc.

Must be taking: HBV nucleos(t)ide

Disqualifiers: Pregnancy, Other liver diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 28

Duration: 96 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called brelovitug for individuals with chronic hepatitis delta virus (HDV) infection. The study aims to determine if brelovitug is safe and effective compared to delayed treatment. Participants will begin brelovitug either immediately or after a 24-week delay, allowing for a comparison between these groups. Those with HDV who have high virus levels and liver enzyme issues may be suitable candidates, especially if they are already receiving treatment for hepatitis B. As a Phase 2, Phase 3 trial, this study evaluates brelovitug's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to advancing treatment options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it does require that you are willing to take or are already taking HBV nucleos(t)ide therapy. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that brelovitug, the treatment being tested for hepatitis D, has a promising safety record. In earlier studies, patients taking brelovitug experienced good results with few side effects. Early reports indicate that it is generally well-tolerated, with patients not reporting major negative effects.

Brelovitug has received Breakthrough Therapy designation from the FDA, often indicating strong early evidence of its safety and effectiveness. This designation suggests it may offer benefits over current treatments. The treatment works by targeting and removing harmful particles related to hepatitis B and D from the body.

Overall, existing data suggest that brelovitug is safe for use, with ongoing studies aimed at confirming these findings in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about brelovitug for Hepatitis D because it offers a potentially different approach compared to current treatments like pegylated interferon. Brelovitug is unique due to its varied dosing strategies, including a higher 900 mg dose administered every four weeks and a standard 300 mg dose given weekly, which may provide more flexibility and potentially better patient adherence. Additionally, the delayed treatment approach, starting after 24 weeks, might offer insights into optimizing dosing schedules for better outcomes. These innovative dosing regimens could lead to improved effectiveness and a new standard in managing Hepatitis D.

What evidence suggests that brelovitug might be an effective treatment for hepatitis D?

Research has shown that brelovitug may help treat chronic hepatitis delta virus (HDV) infection. Studies have found that brelovitug reduces the amount of the virus in the blood. It attaches to a protein called HBsAg, part of the virus, and helps neutralize it. Early results showed that about 40% of patients experienced a positive outcome, with the virus undetectable and improved liver function. This trial will evaluate different dosages of brelovitug, including 300 mg and 900 mg, to determine its effectiveness in managing HDV infection. ^{6 7 8 9 10}

Who Is on the Research Team?

Bluejay Therapeutics

Principal Investigator

Bluejay Therapeutics

Are You a Good Fit for This Trial?

This trial is for individuals with chronic hepatitis delta virus (HDV) infection. Participants should not have started any treatment for HDV before joining the study. Specific details about other inclusion or exclusion criteria are not provided.

Inclusion Criteria

I have a long-term hepatitis D virus infection.

HDV RNA >500 IU/mL at Screening

Abnormal ALT (>upper limit of normal) at Screening

Exclusion Criteria

Unwilling to comply with contraception requirements during the study

Pregnant or nursing females

Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Delayed Treatment

Participants in Arm 3 delay treatment with brelovitug for 24 weeks while attending study clinic visits

24 weeks

Regular clinic visits

Treatment

Participants receive brelovitug 300 mg subcutaneously once weekly or 900 mg once every 4 weeks

96 weeks

Weekly or every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Visits at Weeks 24, 48, 96, and 120

What Are the Treatments Tested in This Trial?

Interventions

• Brelovitug

Trial Overview The trial is testing the safety and effectiveness of a drug called brelovitug, also known as BJT-778, in two different doses (900 mg and 300 mg). It compares immediate treatment with brelovitug to a delayed start of the same drug after 24 weeks.

How Is the Trial Designed?

Group I: Brelovitug 900mg Experimental Treatment 1 Intervention

Dose - brelovitug 900 mg Frequency- once every 4 weeks

Group II: Brelovitug 300mg Experimental Treatment 1 Intervention

Dose - brelovitug 300 mg Frequency- once weekly

Group III: Delayed Treatment with brelovitug 300mg Active Control 1 Intervention

Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly

Who Is Running the Clinical Trial?

Bluejay Therapeutics, Inc.

Lead Sponsor

Published Research Related to This Trial

Bulevirtide (BLV) shows promising early virological efficacy in treating chronic hepatitis delta (CHD), with four out of six patients experiencing significant declines in HDV viral load after 12 and 24 weeks of treatment, especially those receiving combination therapy with pegylated interferon.

The treatment was generally well-tolerated, although one patient experienced thrombocytopenia leading to treatment cessation, highlighting the need for monitoring side effects. Overall, these preliminary results support the potential of BLV as a new therapeutic option for CHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early virological response in six patients with hepatitis D virus infection and compensated cirrhosis treated with Bulevirtide in real-life. Asselah, T., Loureiro, D., Le Gal, F., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07200908

A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for ... This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of ...

2. bluejaytx.com bluejaytx.com/category/press-releases/

Press Release Bluejay Therapeutics Enrolls First Patient in AZURE-2 Global Phase 3 Clinical Trial Evaluating Brelovitug (BJT-778) Compared to Hepcludex (R) ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12390690/

Updates on Recent Advancements in Hepatitis D Virus ... The rates of the composite outcome of undetectable HDV RNA and biochemical response at 48 weeks post-treatment were 25%, 22%, 40%, and 8%, respectively. In ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/bluejay-hepatitis-d/

First subject enrolled in Bluejay's trial of Hepatitis D treatment Bluejay has enrolled the first subject in the randomised AZURE-2 global Phase III clinical trial to assess antibody brelovitug.

5. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/news/brelovitug-granted-breakthrough-designation-for-chronic-hepatitis-delta/

Brelovitug Granted Breakthrough Designation for Chronic ... By binding to HBsAg, brelovitug is expected to neutralize and clear hepatitis B and D virions and deplete HBsAg-containing subviral particles.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06907290

A Trial Evaluating BJT-778 vs Delayed Treatment for the ... This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta ...

7. bluejaytx.com bluejaytx.com/bluejay-therapeutics-brelovitug-bjt-778-monotherapy-achieved-100-virologic-response-and-up-to-82-combined-endpoint-of-virologic-response-and-alt-normalization-at-week-48-in-phase-2-study-in/

Bluejay Therapeutics' Brelovitug (BJT-778) Monotherapy ... Parallel declines in hepatitis D virus (HDV) viral load and ALT were observed across all doses, indicating a beneficial effect on liver ...

8. empr.com empr.com/news/brelovitug-granted-breakthrough-designation-for-chronic-hepatitis-delta/

Brelovitug Granted Breakthrough Designation for Chronic ... By binding to HBsAg, brelovitug is expected to neutralize and clear hepatitis B and D virions and deplete HBsAg-containing subviral particles.

9. eatg.org eatg.org/hiv-news/brelovitug-receives-fda-breakthrough-therapy-designation-for-chronic-hepatitis-delta/

Brelovitug receives FDA Breakthrough Therapy ... Brelovitug (BJT-778) received FDA Breakthrough Therapy designation for chronic hepatitis delta, showing promising phase 2 results with 100% virologic ...

10. contagionlive.com contagionlive.com/view/first-patient-enrolled-in-phase-3-study-for-hepatitis-d-treatment

First Patient Enrolled in Phase 3 Study for Hepatitis D ... Brelovitug, a weekly self-administered monoclonal antibody, targets both HBV and HDV, offering a potentially more convenient and safer option ...