All studies
Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

This study is testing a new medicine, Brelovitug, for people with long-term Hepatitis Delta infection. We want to find out if it's safe and effective. Participants will either start taking Brelovitug right away at different doses, or start it after 24 weeks. This delayed treatment period allows researchers to compare results. Everyone in the study will have regular check-ups, blood tests, and other assessments to monitor their health whether they are taking the medicine or waiting to start. The main goal is to see if Brelovitug can help improve the condition for those with Hepatitis Delta.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
Mirum Pharmaceuticals, Inc.
Enrolment target
150
Start
25 Mar 2025
Estimated completion
01 Sep 2029

What is this study about?

This research study is about a new medicine called Brelovitug (also known as BJT-778) for a condition called chronic Hepatitis Delta. This is a long-term liver infection caused by the Hepatitis Delta virus. Researchers want to see if Brelovitug can help treat this condition and if it's safe for people to take.

In this study, some people will start taking Brelovitug straight away, in different amounts (either 300 mg once a week or 900 mg once every four weeks). Other people will be asked to wait 24 weeks before they start the medicine. During this waiting period, they will still come for all their appointments and have the same tests as those who start treatment immediately. This helps the researchers understand the effects of the medicine better.

After 24 weeks, everyone in the study, including those who waited, will start taking Brelovitug 300 mg once a week. The study will look closely at how participants respond to the treatment and any side effects they might experience. This information is important to help doctors understand the best way to use Brelovitug to help people with chronic Hepatitis Delta.

Key takeaways

  • This study is for adults with long-term Hepatitis Delta infection.
  • It tests a new medicine called Brelovitug to see if it's safe and effective.
  • Participants will either start the medicine right away or after a 24-week delay.
  • Regular clinic visits and tests are part of taking part, whether you're on medicine or waiting.
  • Everyone in the study will eventually receive the new medicine.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. You need to have a long-term Hepatitis Delta infection that is currently active, meaning your virus levels are above a certain point and your liver enzyme (ALT) levels are also abnormal. You must also be willing to take or already be taking medicine for Hepatitis B, as these two infections often go hand-in-hand.

There are also some reasons why you might not be able to join. For instance, if you are pregnant or breastfeeding, or if you can't or won't use birth control during the study. You also can't have other serious liver problems besides Hepatitis B or Delta, like certain types of fatty liver disease or liver cancer. If you have serious signs of liver failure, like fluid in your belly or confusion, or if you've had an organ transplant, you also wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a long-term (chronic) Hepatitis Delta infection?
  3. Are your Hepatitis Delta virus levels currently active?
  4. Are your liver enzyme (ALT) levels currently abnormal?
  5. Are you able to use birth control if needed?
  6. Do you already take or are you willing to take medicine for Hepatitis B?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of three groups. Two groups will start taking the study medicine, Brelovitug, right away. One of these groups will get 300 mg once a week, and the other will get 900 mg once every four weeks. The medicine is given as an injection under the skin.

The third group will wait 24 weeks before starting the medicine. During this waiting period, you will still come to the clinic for regular check-ups, blood tests, and other health assessments, just like the groups taking the medicine. After these 24 weeks, everyone in this group will then start taking Brelovitug 300 mg once a week.

Throughout the study, regardless of which group you are in, you will have regular visits to the clinic for various tests. These include blood tests to check your liver and virus levels, and other health evaluations. The study will continue for a period to properly assess the effects of the treatment. The total duration of your participation will depend on the study design, but you should expect continued monitoring after you start treatment.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as access to a new medicine before it's widely available, which could potentially improve your Hepatitis Delta condition. However, it's also important to be aware of potential risks. As with any new medicine, there could be side effects that are not yet fully known. These might include reactions at the injection site or other effects on your body. You will be closely monitored for any problems. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

  • 247 Garden Grove
    Verified postcode
    Garden Grove, United States
  • 242 Huntington Beach
    Verified postcode
    Huntington Beach, United States
  • 252 Long Beach
    Verified postcode
    Long Beach, United States
  • 244 Los Angeles
    Verified postcode
    Los Angeles, United States
  • 250 Miami
    Verified postcode
    Miami, United States
  • 251, Illinois
    Verified postcode
    Chicago, United States
  • 248 Lowa
    City only
    Cities in Iowa, United States
  • 254 Baltimore
    Verified postcode
    Baltimore, United States
  • 241, Massachusetts
    Verified postcode
    Boston, United States
  • 245 New York
    Verified postcode
    New York, United States
  • 256 New York
    Verified postcode
    New York, United States
  • 253 New York
    Verified postcode
    New York, United States

Common questions

What is Hepatitis Delta?

Hepatitis Delta is a serious liver infection. It only affects people who already have Hepatitis B. Over time, it can cause severe liver damage.

What is Brelovitug (BJT-778)?

Brelovitug is a new medicine being tested to treat chronic Hepatitis Delta. This study aims to see if it's safe and effective.

Will I definitely get the new medicine?

Yes, everyone in the study will eventually receive Brelovitug. Some will start it immediately, while others will start after 24 weeks.

How will the medicine be given?

The medicine, Brelovitug, will be given as an injection just under your skin.

What if I change my mind about taking part?

You can leave the study at any time you wish, for any reason, and it won't affect your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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