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Study on the Safety and Tolerability of Imdusiran and Durvalumab for Patients with Chronic Hepatitis B

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What is this study about?

This clinical trial is focused on studying the treatment of Chronic Hepatitis B Virus (HBV) Infection. The study involves two medications: Imdusiran, also known by its code name AB-729, and Durvalumab, which is a type of medication called a PD-L1 Monoclonal Antibody. The purpose of the study is to evaluate the safety and tolerability of these medications when used together in people with chronic HBV infection.

Participants in the study will receive multiple doses of Imdusiran through an injection under the skin, and Durvalumab will be given through an infusion into a vein. The study will observe how well participants tolerate these medications over a period of time. The study will also monitor any side effects or changes in health that may occur during the treatment.

The study is designed to help researchers understand how these medications work together in treating chronic HBV infection. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather important information about the effects of the treatment. The study aims to provide valuable insights that could lead to improved treatments for people living with chronic HBV infection.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, health status, and chronic HBV infection documentation.

A liver ultrasound and fibrosis assessment are required to ensure non-cirrhotic status.

2 treatment initiation

The treatment phase begins with the administration of Imdusiran (AB-729) and Durvalumab. Imdusiran is given as a subcutaneous injection, while Durvalumab is administered through intravenous infusion.

The specific dosage and frequency of administration are determined by the study protocol and are tailored to each participant’s needs.

3 monitoring and follow-up

Regular monitoring is conducted to evaluate the safety and tolerability of the medications. This includes checking for any adverse effects and conducting laboratory tests.

Vital signs, physical exams, and electrocardiograms (ECGs) are performed periodically to ensure participant safety.

4 completion of treatment

The treatment phase continues until the study’s end date, estimated to be July 31, 2027.

Upon completion, a final assessment is conducted to evaluate the overall health and response to the treatment.

Who Can Join the Study?

  • The person must be between 18 and 65 years old when they agree to join the study.
  • The person must be able to understand the study details, agree to follow the study rules, and be likely to finish the study.
  • The person must have a Body Mass Index (BMI) between 18 and 38. BMI is a measure of body fat based on height and weight.
  • For men: They must not have a partner who is pregnant or planning to become pregnant during the study. They must agree to use birth control starting 4 weeks before the study begins, during the study, and for 3 months after the study ends. They should not donate sperm during this time.
  • For women: They must not be pregnant or breastfeeding. If they can become pregnant, they must agree to use birth control starting 4 weeks before the study begins, during the study, and for 3 months after the study ends.
  • The person must have a documented chronic HBV infection. This means they have had a positive test for hepatitis B virus (HBV) for at least 6 months before the study starts and a negative test for a specific antibody related to hepatitis B at the start of the study.
  • The person can be either positive or negative for a specific hepatitis B antigen called HBeAg.
  • The person must have a specific level of hepatitis B surface antigen (HBsAg) that is 1,000 IU/mL or less at the start of the study.
  • The person must have a liver ultrasound showing no significant problems within 6 months before the study starts.
  • The person must have a test showing they do not have cirrhosis, which is severe liver damage. This can be shown by a liver biopsy with a Metavir Fibrosis Score of F0-2 within 12 months before the study starts, or a Fibroscan result of 8.5 kPa or less within 6 months before the study starts.

Who Cannot Join the Study?

  • Individuals who are not able to follow the study procedures or instructions.
  • People with other serious health conditions that might interfere with the study.
  • Participants who are pregnant or breastfeeding.
  • Individuals who have had a recent infection or illness that could affect the study results.
  • People who are currently participating in another clinical trial.
  • Individuals with a history of allergic reactions to the study medications.
  • Participants who have used certain medications that might interfere with the study.
  • People with a history of substance abuse or alcohol dependency.
  • Individuals who have had a recent surgery or medical procedure.
  • Participants with a history of mental health conditions that might affect their ability to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
ID Clinic Myslowice Poland
Hospital Clinic De Barcelona Barcelona Spain
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
Pmqpw Zzsgjbx Heniudgdv Jjeadypcmp Lgmikev scb pc Gdansk Poland
Hsdixepm Vvjt dakcwlgd Barcelona Spain
Cql Cyzsg Rlhhbvkofzq Lyon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
30.04.2024
Poland Poland
Not recruiting
30.04.2024
Romania Romania
Not recruiting
30.04.2024
Spain Spain
Not recruiting
30.04.2024

Trial locations

Investigated drugs:

Imdusiran (AB-729) is a medication being studied for its potential to help treat chronic hepatitis B infection. It is designed to work by targeting specific parts of the virus, potentially reducing its ability to replicate and cause harm in the body. The goal of using imdusiran in this trial is to assess its safety and how well it is tolerated by patients.

Durvalumab is a type of medication known as a PD-L1 monoclonal antibody. It is used to help the immune system recognize and attack cancer cells. In this trial, durvalumab is being used in combination with imdusiran to see if it can enhance the body’s immune response against the hepatitis B virus, potentially improving treatment outcomes for patients with chronic hepatitis B infection.

Chronic Hepatitis B Infection – This is a long-term infection caused by the hepatitis B virus, which affects the liver. Over time, the virus can lead to liver inflammation and damage. The disease progresses slowly, often over many years, and can result in liver scarring, known as cirrhosis. In some cases, the infection may remain inactive, but it can reactivate, causing further liver damage. Chronic hepatitis B is primarily spread through contact with infectious body fluids, such as blood. The progression of the disease can vary greatly among individuals, with some experiencing minimal symptoms and others developing significant liver complications.

Trial ID:
2023-509573-23-00
Protocol code:
AB-729-203
NCT ID:
NCT06245291
Trial Phase:
Therapeutic exploratory (Phase II)

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