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

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Spitalul Clinic De Boli Infectioase Constanta	Constanta	Romania
Eugastro GmbH	Leipzig	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Hospital General Universitario De Valencia	Valencia	Spain
Institutul National De Boli Infectioase Prof.Dr.Matei Bals	Bucharest	Romania
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes	Bucharest	Romania
Centrul Medical Renasterea S.R.L.	Craiova	Romania
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Fundeni Clinical Institute	Bucharest	Romania
Hvnjdsrp Urvitmycpqfns Monjyrs Df Vnibtyblcj	Santander	Spain
Gyzfrm Ukkhwzhagc Flsirofjp	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	18.05.2023
Romania	Not recruiting	18.05.2023
Spain	Not recruiting	18.05.2023

Trial locations

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.

Investigated diseases:

Chronic hepatitis C

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.

Trial ID:

2023-504566-28-00

Protocol code:

AT-01B-004

NCT ID:

NCT05904470

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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