Brelovitug for Hepatitis D
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and effectiveness of a new treatment called brelovitug for individuals with chronic hepatitis D, a liver infection caused by the hepatitis delta virus. It compares different administration methods, including two doses and a delayed start option. Suitable candidates for this trial include those with chronic hepatitis D who have high virus levels and elevated liver enzyme levels, and who are willing to take antiviral medication for hepatitis B. As a Phase 3 trial, this study serves as the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you must be willing to take or already be taking HBV nucleos(t)ide therapy.
Is there any evidence suggesting that brelovitug is likely to be safe for humans?
Research has shown that brelovitug is generally well-tolerated in studies for treating chronic hepatitis delta virus (HDV) infection. In earlier research, patients using brelovitug reported few serious side effects. This treatment targets and removes the virus from the body, potentially reducing other related viral particles.
In these studies, some patients experienced mild to moderate side effects, but they were manageable. The treatment is designed for self-administration, allowing patients to take it independently, which suggests convenience and safety for long-term use. Overall, brelovitug appears promising as a treatment with a good safety record, but discussing potential risks with a healthcare provider is important.12345Why are researchers excited about this study treatment for hepatitis D?
Unlike the current standard treatments for Hepatitis D, which often involve antiviral therapies like pegylated interferon and liver transplants in severe cases, brelovitug offers a promising alternative. Researchers are excited because brelovitug targets the virus directly with a new active ingredient that is designed to inhibit its replication. Additionally, unlike other treatments that require frequent dosing, brelovitug provides flexibility with one regimen being administered just once every four weeks after an initial loading dose. This combination of a novel mechanism and a potentially more convenient dosing schedule has the potential to improve patient outcomes and ease of use.
What evidence suggests that brelovitug might be an effective treatment for hepatitis D?
Research has shown that brelovitug is highly effective in treating hepatitis D. In earlier studies, brelovitug rendered the virus undetectable in the blood for all participants, regardless of the dose. In this trial, participants will receive different doses of brelovitug: 900 mg every 4 weeks with a loading dose at Week 2, 300 mg once weekly, or a delayed treatment with 300 mg once weekly. Notably, up to 82% of participants in previous studies experienced both the disappearance of the virus and improved liver health, as indicated by normal levels of the liver enzyme ALT. These promising results suggest that brelovitug could be an effective treatment option for chronic hepatitis D.46789
Are You a Good Fit for This Trial?
This trial is for individuals with chronic Hepatitis Delta Virus (HDV) infection who have an HDV RNA level over 500 IU/mL and elevated ALT levels. Participants must be willing to provide consent and take or already be on HBV nucleos(t)ide therapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brelovitug either 300 mg weekly or 900 mg every 4 weeks for 96 weeks
Delayed Treatment
Participants delay treatment for 12 weeks before starting brelovitug 300 mg weekly for 96 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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 at two different doses (900 mg and 300 mg) compared to delayed treatment in patients with chronic HDV infection.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks
Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bluejay Therapeutics, Inc.
Lead Sponsor
Citations
Bluejay Therapeutics' Brelovitug (BJT-778) Monotherapy ...
In this Phase 2 study, brelovitug achieved 100% virologic response across all dose arms and up to 82% of participants reached the combined ...
A Trial Evaluating Brelovitug vs Delayed Treatment for the ...
This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with ...
Updates on Recent Advancements in Hepatitis D Virus ...
According to data at week 48 of treatment, when comparing cirrhotic and noncirrhotic groups, virologic, biochemical, and combined response rates were 66% vs. 65 ...
4.
humanforschung-schweiz.ch
humanforschung-schweiz.ch/en/trial-search/study-detail/67578/translate/en/?cHash=acbe8d0cbd6cec8da6da93547e3893f9A Phase III Study to Evaluate BJT-778 Compared ...
Additionally, the safety and efficacy of Brelovitug will be assessed over 96 weeks. It is possible that your study treatment (Brelovitug or ...
5.
contagionlive.com
contagionlive.com/view/investigational-monoclonal-antibody-for-chronic-hepatitis-d-treatment-begins-clinical-trialInvestigational Monoclonal Antibody for Chronic Hepatitis ...
Previous phase 2 data showed that BJT-778 achieved 100% virologic response across all dose groups, with up to 78% of participants reaching the ...
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 ...
November 10, 2025
Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles, which gives ...
8.
contagionlive.com
contagionlive.com/view/first-patient-enrolled-in-phase-3-study-for-hepatitis-d-treatmentFirst 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 ...
9.
gastroenterologyadvisor.com
gastroenterologyadvisor.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.
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