Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide Treatment

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What is this study about?

This clinical trial is focused on studying a condition known as Chronic Hepatitis D Virus (HDV) Infection. The study is investigating a combination of two treatments, Tobevibart and Elebsiran, to see how effective they are in treating this infection. These treatments are being tested in people who have previously been treated with another medication called Bulevirtide but have not achieved the desired results.

The purpose of the study is to evaluate how well the combination of Tobevibart and Elebsiran works in reducing the virus in the body. Participants in the study will receive these treatments through injections under the skin. The study will be conducted over a period of time, with regular check-ups to monitor the effects of the treatment. The study will also look at how the treatment affects liver health and any side effects that may occur.

Participants will be monitored for changes in their health, including the amount of virus in their blood and the condition of their liver. The study aims to provide valuable information on the effectiveness and safety of the combination therapy for people with Chronic Hepatitis D Virus Infection who have not responded well to previous treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, health status, and current treatment with bulevirtide for at least 24 weeks.

Blood tests are performed to measure HDV RNA levels, which should be at least 500 IU/mL. Liver health is assessed to ensure noncirrhotic or compensated cirrhotic liver disease.

2 treatment initiation

The treatment involves a combination of tobevibart and elebsiran, administered through subcutaneous injections. This means the medication is injected under the skin.

The specific dosage and frequency of these medications are determined by the study protocol and are explained during this phase.

3 ongoing treatment and monitoring

Regular visits are scheduled to monitor health and the effectiveness of the treatment. Blood tests are conducted to measure changes in HDV RNA and liver function.

Participants are observed for any side effects or adverse events. Adjustments to the treatment plan may be made based on these observations.

4 evaluation at week 24

At week 24, a comprehensive evaluation is conducted to assess the reduction in HDV RNA levels. The goal is to achieve levels below the limit of detection.

Liver function tests and other health assessments are performed to ensure the treatment is working effectively.

5 long-term follow-up

Participants continue to receive treatment and are monitored at regular intervals, including weeks 48 and 96, to track long-term effects and health outcomes.

The study aims to observe the sustained response and any potential long-term benefits or risks associated with the treatment.

6 treatment interruption and final evaluation

In the later stages, treatment may be systematically interrupted to evaluate the body’s response without medication. This occurs around week 96.

Final evaluations are conducted up to week 240 to assess the long-term impact of the treatment and any changes in health status.

Who Can Join the Study?

  • Adult men and women aged 18 to 70 years at the time of signing the consent form.
  • Have a level of HDV RNA (a measure of the virus in the blood) of at least 500 IU/mL at the start of the study.
  • Have been receiving BLV 2 mg (a type of medication) as a subcutaneous injection (under the skin) once daily for at least 24 weeks before the first day of the study.
  • Have either noncirrhotic (no severe liver scarring) or compensated cirrhotic (liver scarring that is not causing severe symptoms) liver disease at the start of the study.
  • Have a Body Mass Index (BMI) between 18 kg/m² and 40 kg/m². BMI is a measure of body fat based on height and weight.
  • Be on NRTI therapy (a type of medication for hepatitis B) for at least 12 weeks before the first day of the study, or have a level of HBV DNA (a measure of hepatitis B virus in the blood) less than 20 IU/mL at the start of the study. Participants must be on one of the following NRTI therapies: tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir.

Who Cannot Join the Study?

  • Patients who have a different type of hepatitis infection other than Chronic Hepatitis D Virus (HDV) Infection cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not willing or able to follow the study procedures and requirements cannot participate.
  • Patients who have any other medical condition that the study doctors think might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have a history of substance abuse that could interfere with the study cannot participate.
  • Patients who have a known allergy or adverse reaction to the study medications cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Medizinische Hochschule Hannover Hanover Germany
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes Bucharest Romania
Centrul Medical Renasterea S.R.L. Craiova Romania
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Azienda Sanitaria Locale Citta Di Torino Turin Italy
Centre Hospitalier Universitaire De Rennes Rennes France
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Paul Brousse Villejuif France
Fundeni Clinical Institute Bucharest Romania
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
Faithclt Dvr Vnlqea Boxhq Bucharest Romania
Uwsauetjvqsfknloxfojp Edbop Aaf Essen Germany
Hiakqier Ubqdujfmwnngn Muxcqoh Da Vkvgtyoier Santander Spain
Ccrvzn Haegtchqmux Eq Ulgcexjupkxnh Dw Lqvddtw Limoges France
Avfnijq Odskvcdmzus Uorfhxlyqpyek Cbfppbdnlxsw Dunzg Srdzrl E Dtffo Scqtkfo Dq Tyduap Turin Italy
Anadlft Osxlgsaiazy Unbpzkyzksdwp Oksyncrm Rlqkjlm Foggia Italy
Gxfaze Uqepeuarby Fxojhflzy Frankfurt Germany
Axuyybs Ojkbrrniwve Pwmp Gcioybtu Xmurl Bergamo Italy
Ffbxvedir Pixf Lr Irpbaxhjhqwdj Butsemzsv Djt Hdksnhuy Ucanhrmvejxuq Li Puw Madrid Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.06.2025
France France
Not recruiting
01.06.2025
Germany Germany
Not recruiting
01.06.2025
Italy Italy
Not recruiting
01.06.2025
Romania Romania
Not recruiting
01.06.2025
Spain Spain
Not recruiting
01.06.2025

Trial locations

Tobevibart is a medication being studied for its ability to help people with chronic HDV infection. It is used in combination with another medication to see if it can better control the virus in people who have already been treated with another drug called Bulevirtide but still have the virus in their system. The goal is to see if Tobevibart can help reduce the amount of virus in the body and improve the health of the liver.

Elebsiran is another medication used in this study alongside Tobevibart. It is being tested to see if it can help people with chronic HDV infection achieve a state where the virus is no longer actively affecting their body. This is especially important for people who have been treated before but still have the virus. The combination of Elebsiran with Tobevibart is being evaluated to see if it can provide better results in controlling the infection and improving liver health.

Investigated diseases:

Chronic Hepatitis D Virus (HDV) Infection – This disease is a liver infection caused by the hepatitis D virus, which requires the presence of hepatitis B virus to replicate. It is characterized by inflammation of the liver, which can lead to liver damage over time. The progression of the disease can vary, with some individuals experiencing mild symptoms, while others may develop severe liver complications. Over time, chronic HDV infection can lead to fibrosis, cirrhosis, and liver failure. The disease is primarily spread through contact with infected blood or bodily fluids. Managing the disease involves monitoring liver function and preventing further liver damage.

Trial ID:
2024-519282-22-00
Protocol code:
VIR-CHDV-V205
NCT ID:
NCT07128550
Trial Phase:
Therapeutic confirmatory (Phase III)

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