Brelovitug for Hepatitis D

Recruiting at 3 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

Trial Summary

What is the purpose of this trial?

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 virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.

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.

What data supports the effectiveness of the drug Brelovitug for treating Hepatitis D?

Bulevirtide, a drug similar to Brelovitug, has shown promise in treating Hepatitis D, with reports of over 50% response rates and good tolerability. It has been conditionally approved in Europe and has demonstrated effectiveness in reducing the virus in patients with chronic Hepatitis Delta. ^{1 2 3 4 5}

What safety data exists for Brelovitug (Bulevirtide) in humans?

Bulevirtide, used for treating hepatitis D, has shown a good safety profile in early reports, with some patients experiencing elevated biliary acids but no itching. One patient stopped treatment due to low platelet count, but overall, it appears to be well-tolerated. ^{2 3 5 6 7}

How does the drug Brelovitug differ from other treatments for Hepatitis D?

Brelovitug, also known as Bulevirtide, is unique because it is an entry inhibitor specifically approved for treating chronic Hepatitis D, which is the most severe form of viral hepatitis. Unlike traditional treatments like pegylated interferon, Bulevirtide directly targets the virus's ability to enter liver cells, offering a new mechanism of action and showing promising response rates. ^{2 3 4 5 8}

Research Team

Bluejay Therapeutics

Principal Investigator

Bluejay Therapeutics

Eligibility Criteria

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.

I am willing to start or am already on HBV therapy.

HDV RNA >500 IU/mL 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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of seven interventions for chronic hepatitis D: a systematic review and network meta-analysis of randomized controlled trials. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Hepatitis D Review: Challenges for the Resource-Poor Setting. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Bulevirtide monotherapy for 48 weeks in patients with HDV-related compensated cirrhosis and clinically significant portal hypertension. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A 3-Year Course Of Bulevirtide Monotherapy May Cure Hdv Infection In Cirrhotics. [2023]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Side Effects of Nucleoside and Nucleotide Drugs Used for Treatment of Chronic Hepatitis B. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Low-dose adefovir dipivoxil-induced hypophosphatemia osteomalacia in five chronic hepatitis B virus-infected patients. Is low-dose adefovir dipivoxil-induced nephrotoxicity completely reversible? [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Hepatitis D: forgotten but not gone]. [2018]