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What is Hepatitis D?

Hepatitis D is a severe liver disease caused by the Hepatitis D virus (HDV). This virus is known as a “satellite virus” because it can only infect people who already have Hepatitis B. Around 12 to 74 million people around the world are thought to have Hepatitis D.1 Common symptoms include fever, stomach pain, nausea, vomiting, and loss of appetite. In some cases, the infection goes away without treatment. As long-term (chronic) Hepatitis D gets worse, it can cause liver scarring, called cirrhosis. About 1 in 4 people with cirrhosis from long-term Hepatitis D may die from liver failure and have a higher chance of getting liver cancer.2 In the U.S., there are few treatment options for long-term Hepatitis D.

Chronic Hepatitis D Virus (HDV) Clinical Study

This clinical study, also known as a clinical trial, is testing an injectable medicine to see if it is safe and works well for people with long-term Hepatitis D.

  • This study is testing an investigational injectable medication. There is no placebo in this study.
  • Participants will receive the investigational medication once a week or once a month for two years.
  • Study procedures and tests will include physical exams, laboratory tests, ultrasounds, and questionnaires.

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Eligibility Requirements

Participants must be:

Ages

18 years or older

Diagnosed

Diagnosed with chronic hepatitis D virus infection

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All participants will receive the investigational medication.

Benefits of Participation

Doctor's Visits

As simple as a doctor’s visit

Get seen by top doctors in their field at no cost to you. Follow-up visits may be required.

No-cost Study-related Medical Care

No-cost study-related medical care

Participants can receive new and advanced medical treatment by leading doctors and hospitals.

Financial Compensation

Earn money for your time

Financial compensation varies by study, you can earn compensation for your time and travel.

Research

Make an impact through research

Taking part in a clinical study helps advance science and care for others facing similar health challenges.

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What to Expect

  • Step 1

    Prescreening

  • Step 2

    Study Enrollment

  • Step 3

    Trial Participation

The first step towards enrollment is to see if you pre-qualify for this study. If your medical condition and symptoms match the study criteria, you will be contacted by a study coordinator for further evaluation. If you do not qualify for this specific trial, you can submit your contact information, and we will contact you if you match new trials in the future.

After pre-qualification, the next step is to have an in-person appointment at a local study site to enroll in the research study. Study sites are medical facilities (such as hospitals, clinics and universities) where study-related activities will occur. At your first visit, you will receive additional information about the trial. You will be required to complete further screening at the study site to confirm your eligibility.

Before fully enrolling in the study, participants will read and sign an informed consent document that gives a full explanation of all activities that will happen during the study. This consent document is not a contract, and participants can withdraw their consent from the study at any time.

Participation will last approximately 2 years and 5 months. During the study, you will be asked to come to the study site approximately 33 times, including an initial screening visit to see if you are eligible for the study. Additional procedures include physical exams, laboratory tests, ultrasounds, and questionnaires.

To get started, take the private online pre-screener questionnaire.

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Frequently Asked Questions

Who is sponsoring this trial?

This trial is being paid for by Bluejay Therapeutics, a pharmaceutical company. Bluejay Therapeutics is one of the developers of the investigational medication in this study.

Will I receive the investigational medication/study drug if I participate in this trial?

All enrolled participants will receive the investigational medication.

Will I receive a placebo if I participate in this trial?

No, there is no placebo in this study.

Will I have health checks?

All participants will be monitored for adverse reactions to the investigational medication and will attend regularly scheduled follow-up visits during the study per the protocol.

Why should I join this study?

Participants in this study may benefit from receiving a treatment that helps their immune system better recognize and combat hepatitis B surface antigens (HBsAg). This approach could potentially reduce or even halt the hepatitis D virus’s ability to replicate and spread.

If I participate, can I continue my current medications?

If you’re already on a hepatitis B medication like tenofovir or entecavir, you’ll keep taking it during the study or may be asked to start one. The study team will carefully review your medications and decide which ones can be continued, adjusted, or stopped before the study begins.

What phase of the trial is being conducted?

This is a Phase 2b/3 clinical trial

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References

    1. National Organization for Rare Disorders. “Hepatitis D,” February 6, 2025. https://rarediseases.org/rare-diseases/hepatitis-d/.
    2. “Hepatitis D.” Accessed August 7, 2025. https://www.sahealth.sa.gov.au