Study on the Effects of Selgantolimod and NUC Discontinuation in 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 (CHB), a liver infection caused by the hepatitis B virus. The study involves several medications: Vemlidy (containing the active substance tenofovir alafenamide), Viread (containing tenofovir disoproxil), Baraclude (containing entecavir), and a new investigational drug called Selgantolimod (also known by its code name GS-9688). These medications are taken orally, either as film-coated tablets or as an oral solution.

The purpose of the study is to explore the effectiveness of stopping the use of nucleos(t)ide analogues (NUC), which are standard treatments for CHB, after treatment with Selgantolimod. The study will compare this approach to the continuous use of NUC over a period of 76 weeks. Participants will be divided into groups, with some continuing their NUC treatment and others stopping it after receiving Selgantolimod. The study aims to see if this new approach can lead to a significant reduction in the virus levels in the body.

Participants will be monitored over the course of the study, which lasts for about 76 weeks. During this time, they will have regular check-ups to assess their health and the levels of the virus in their blood. The study will also look at the overall health-related quality of life of the participants. The goal is to find out if the new treatment strategy can help manage Chronic Hepatitis B more effectively than the current standard of care.

1 initial treatment phase

Begin taking Vemlidy 25 mg film-coated tablets orally once daily. This medication contains tenofovir alafenamide.

Continue this medication as prescribed by the study protocol.

2 treatment adjustment phase

Switch to Viread 245 mg film-coated tablets, which contain tenofovir disoproxil, or Baraclude 0.05 mg/ml oral solution, which contains entecavir, as directed by the study team.

These medications are also taken orally once daily.

3 selgantolimod administration

Begin taking Selgantolimod film-coated tablets orally as part of the study protocol.

The dosage and frequency will be specified by the study team.

4 nuc discontinuation phase

Discontinue nucleos(t)ide analogues (NUC) as instructed by the study protocol.

This phase aims to evaluate the body’s response to stopping NUC treatment.

5 monitoring and follow-up

Regular monitoring of health status and liver function will occur throughout the study.

Blood tests and other assessments will be conducted at specified intervals to track progress and response to treatment.

6 final assessment

At the end of the study period, a comprehensive evaluation will be conducted to assess the overall effectiveness of the treatment.

This includes measuring changes in specific markers related to liver health and viral activity.

Who Can Join the Study?

Patients must have HBeAg negative CHB (a type of chronic hepatitis B) and have been on documented NUC (nucleos(t)ide analogs) treatment for at least 3 years, with HBV DNA levels less than 20 IU/mL, confirmed at least 3 times over the last 1.5 years. The NUC treatment can include only tenofovir/TDF, tenofovir/TAF, or entecavir.
Women who can have children must agree to use a highly effective method of contraception during the study and for 7 days after the last dose of the study drug. Men with female partners who can have children must also agree to use a highly effective method of contraception during the study and for 7 days after the last dose of the study drug.
A Screening Electrocardiogram (ECG) must show no significant abnormalities, and the QTcF interval (a measure of heart rhythm) must be 450 milliseconds or less for males and 470 milliseconds or less for females.
Participants must be willing and able to follow all study requirements.
Participants must be able to understand and sign a written informed consent form (ICF).
Participants must have health insurance if required by local regulations.
HBsAg levels must be between 100 IU/mL and 6,000 IU/mL at screening.
Participants must be between 18 and 70 years old at the time of screening.
An ultrasound, CT scan, or MRI within 6 months of screening must show no signs of hepatocellular carcinoma (HCC), a type of liver cancer.
No signs of advanced liver scarring (fibrosis) or cirrhosis at screening, with a Fibroscan value of 9 kPa or less, normal ultrasound results, and platelet count of 150×10⁹/L or more.
No evidence of cirrhosis before starting NUC therapy.
HBV DNA levels must be less than 20 IU/mL at screening.
ALT levels (a liver enzyme) must be 1.5 times the upper limit of normal (ULN) or less at screening.
Women who can have children must have a negative urine or blood pregnancy test within 24 hours before the first dose of the study drug. If the urine test is positive, a follow-up blood test is needed to confirm.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with other serious health conditions that might interfere with the study cannot join.
People who have participated in another clinical trial recently may be excluded.
Patients who are unable to follow the study procedures or attend scheduled visits might not be eligible.
Individuals with a history of alcohol or substance abuse that could affect the study results may be excluded.
Patients with known allergies to the study medication or its ingredients cannot participate.
Individuals who have received certain treatments or medications that could interfere with the study may be excluded.
Patients with a history of non-compliance with medical treatments might not be eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Ucdamcdupvp Kttxaaif	Freiburg Im Breisgau	France
Azfychh Ohwncgylvai Ujalrumlmxdac Ppxji	Parma	Italy
Hmcguiip Vdad dsernrtx	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.02.2022
Germany	Not recruiting	01.02.2022
Italy	Not recruiting	01.02.2022
Spain	Not recruiting	01.02.2022

Trial locations

Investigated drugs:

NUC is a type of medication used to treat chronic hepatitis B. It works by reducing the amount of the virus in the body, helping to prevent liver damage. In this trial, NUC is used as a standard treatment for patients with hepatitis B, and its effects are being compared to other treatment strategies.

SLGN is a treatment being studied in this trial. It is used to stimulate the immune system in the liver, potentially helping the body to fight off the hepatitis B virus more effectively. The trial is investigating whether using SLGN before stopping NUC treatment can improve the outcomes for patients with hepatitis B.

Hepatitis B – Hepatitis B is a viral infection that affects the liver and can lead to both acute and chronic disease. The virus is transmitted through contact with the blood or other body fluids of an infected person. In the early stages, individuals may experience symptoms such as jaundice, fatigue, abdominal pain, and nausea. As the disease progresses, it can cause liver inflammation, fibrosis, and cirrhosis. Chronic Hepatitis B can persist for years and may lead to serious liver damage over time. The progression of the disease varies among individuals, with some experiencing mild symptoms and others developing severe liver complications.

Trial ID:

2024-515739-32-00

Protocol code:

ANRS HB07 IP-Cure-B

NCT ID:

NCT05045261

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Selgantolimod and NUC Discontinuation in Patients with Chronic Hepatitis B

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?