Not recruiting

Study on the Safety and Effectiveness of Bemnifosbuvir and Ruzasvir for Patients with Chronic Hepatitis C

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Chronic Hepatitis C Virus (HCV) Infection, a long-lasting viral infection that affects the liver. The study will use two medications: Bemnifosbuvir Hemisulfate, also known as BEM, which is taken in tablet form, and Ruzasvir, also known as RZR, which is taken in capsule form. Both medications are antivirals, meaning they are designed to fight viruses in the body.

The purpose of the study is to evaluate the safety and effectiveness of these medications when used together. Participants will take the medications for a period of up to eight weeks. After completing the treatment, the study will continue to monitor participants for an additional 12 weeks to see if the virus remains undetectable in their blood, which is referred to as a sustained virologic response.

Throughout the study, participants will be regularly checked to ensure the treatment is safe and to observe how well it works in reducing the virus. The study aims to provide valuable information on whether this combination of medications can be a successful treatment option for people with chronic HCV infection.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will provide written informed consent, confirming your willingness to participate.
A series of assessments will be conducted to ensure eligibility, including a review of your medical history and a liver disease staging assessment. Female participants of childbearing potential will undergo a pregnancy test.
Step 2
Medication administration
You will begin taking the study medications, ruzasvir and bemnifosbuvir hemisulfate. These medications are administered orally, meaning you will swallow them.
The medications are provided in the form of a capsule and a tablet. You will be instructed on the specific dosage and frequency of administration by the study team.
Step 3
Treatment period
Throughout the treatment period, you will continue taking the medications as directed. Regular follow-up visits will be scheduled to monitor your health and the effectiveness of the treatment.
During these visits, various tests and assessments will be conducted to evaluate your response to the treatment and to ensure your safety.
Step 4
Post-treatment follow-up
After completing the treatment, you will enter a follow-up phase. This phase includes monitoring your health and assessing the sustained virologic response at 12 weeks post-treatment, known as SVR12.
Additional assessments may be conducted to evaluate the long-term effects of the treatment and to ensure no relapse of the infection.

Who can join the trial?

8 criteria

Willing and able to provide written informed consent, which means you agree to participate after understanding the study details.
Must be a male or female between the ages of 18 and 85.
Female subjects of childbearing potential must agree to either not have heterosexual intercourse or use effective birth control methods.
Females of childbearing potential must have a negative pregnancy test at the start of the study and on the first day of treatment.
Must not have been treated with any approved or experimental direct-acting antiviral (DAA) medications for Hepatitis C before. This means you have never taken certain types of drugs specifically for Hepatitis C.
Must have a documented medical history that is consistent with having chronic Hepatitis C.
Liver disease must be assessed and fall into one of the following categories:
- Absence of cirrhosis, which means no severe liver scarring (F0 to F3).
- Compensated cirrhosis, which means liver scarring is present but the liver still functions well (F4).

Who cannot join the trial?

10 criteria

Patients with any other significant liver disease apart from Chronic Hepatitis C Virus (HCV) Infection.
Patients who have had a liver transplant.
Patients with a history of drug or alcohol abuse within the last 12 months.
Patients who are pregnant or breastfeeding.
Patients with severe heart problems.
Patients with uncontrolled diabetes.
Patients with any other serious medical condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a severe allergic reaction to any of the study medications.
Patients with a history of cancer within the last 5 years, except for certain types of skin cancer.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Goethe University Frankfurt
Frankfurt, Germany
Verified
Hospital General Universitario De Valencia
Valencia, Spain
Verified
Hospital Universitario Marques De Valdecilla
Santander, Spain

Trial locations

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Investigated drugs

Bemnifosbuvir
is a medication being studied for its ability to treat chronic Hepatitis C virus infection. It works by interfering with the virus's ability to multiply in the body, which may help reduce the amount of virus in the blood and improve liver health. The goal of using Bemnifosbuvir in this trial is to see if it can help patients achieve a sustained virologic response, meaning the virus remains at undetectable levels in the blood for a period after treatment ends.
Ruzasvir
is another medication being tested in this trial for its effectiveness in treating chronic Hepatitis C virus infection. Like Bemnifosbuvir, Ruzasvir aims to stop the virus from replicating, which can help lower the viral load in the body. The combination of Ruzasvir with Bemnifosbuvir is being evaluated to see if it can improve the chances of achieving a sustained virologic response, where the virus stays at very low levels in the blood even after the treatment has finished.

What is already known about the treatment

Bemnifosbuvir
Bemnifosbuvir is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating chronic Hepatitis C Virus (HCV) infection. It is not yet widely used in medicine, as it is still under investigation. The medication works by targeting the virus at a molecular level, inhibiting its ability to replicate and spread within the body. Bemnifosbuvir is classified as an antiviral drug, specifically designed to combat viral infections like HCV.
Ruzasvir
Ruzasvir is also taken orally and is being evaluated in clinical trials alongside Bemnifosbuvir for the treatment of chronic Hepatitis C Virus (HCV) infection. It is not yet approved for general medical use, as research is ongoing to determine its safety and effectiveness. Ruzasvir functions by interfering with the virus's replication process, helping to reduce the viral load in the body. It belongs to the class of antiviral medications aimed at treating viral infections such as HCV.

Investigated diseases

Chronic Hepatitis C Virus (HCV) Infection – This disease is a long-term infection caused by the hepatitis C virus, primarily affecting the liver. It often begins with mild symptoms or none at all, making it difficult to detect in its early stages. Over time, the virus can lead to liver inflammation and damage, potentially resulting in scarring of the liver tissue, known as fibrosis. As the disease progresses, it may advance to cirrhosis, where the liver becomes severely scarred and its function is impaired. In some cases, chronic HCV infection can lead to complications such as liver failure or liver cancer. The progression of the disease varies among individuals, influenced by factors such as the duration of infection and overall health.