Ongoing Clinical Trials for Chronic Hepatitis C
Currently, there are 2 ongoing clinical trials for chronic hepatitis C investigating combination antiviral treatments aimed at eliminating the virus from the body. These studies compare new treatment options with existing therapies and evaluate their safety and effectiveness in adult patients with this long-term liver infection.
Clinical trial locations
- France
- Germany
- Greece
- Poland
- Romania
- Spain
Comparing bemnifosbuvir-ruzasvir and sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in adult patients
This trial compares two combination antiviral treatments for people living with chronic hepatitis C. The study investigates whether Bemnifosbuvir-Ruzasvir (BEM/RZR) works as effectively as Sofosbuvir-Velpatasvir (SOF/VEL), an established treatment option. Both medications are taken as tablets once daily and work by directly targeting the hepatitis C virus to stop it from multiplying in the body.
Main inclusion criteria: Participants must be adults between 18 and 70 years old who have never received direct-acting antiviral medications for hepatitis C before. Both men and women can participate, though women who can become pregnant must use effective birth control. Eligible participants must have documented long-term hepatitis C infection and either no liver scarring or early-stage compensated cirrhosis (mild liver scarring that doesn’t significantly affect liver function). People living with HIV can also participate if they are on stable HIV treatment for more than 8 weeks, have a CD4 count above 200 cells/mm3, undetectable HIV levels, and are taking HIV medications that don’t interact with the study drugs.
Main exclusion criteria: People who have previously received direct-acting antiviral treatments for hepatitis C cannot participate. Those co-infected with hepatitis B virus or HIV (unless meeting the specific HIV criteria above), pregnant or breastfeeding women, and individuals with severe liver cirrhosis are excluded. Other exclusions include significant heart, kidney, or other organ disorders, active substance abuse within the past six months, current use of medications that could interact with study drugs, history of liver cancer or other cancers in the past five years, abnormal blood tests showing poor liver or kidney function, mental health conditions that could affect participation, inability to take oral medications, and participation in another clinical trial within the past 30 days.
Trial focus: The study aims to determine whether BEM/RZR, given for either 8 or 12 weeks, is as effective as SOF/VEL given for 12 weeks. Participants are randomly assigned to receive one of these treatment combinations and will be monitored through regular blood tests to measure virus levels. The main goal is to see if the virus is cleared from the body and remains undetectable 24 weeks after treatment begins, indicating successful treatment.
Investigational drugs: Bemnifosbuvir-Ruzasvir is a combination antiviral medication designed to stop the hepatitis C virus from multiplying. Sofosbuvir-Velpatasvir is also a combination antiviral that interferes with proteins the virus needs to replicate. Both are taken once daily and represent different treatment approaches for eliminating the virus from the patient’s system.
Study on the Safety and Effectiveness of Bemnifosbuvir and Ruzasvir for Patients with Chronic Hepatitis C
This clinical trial evaluates the safety and effectiveness of two medications used together to treat chronic hepatitis C: Bemnifosbuvir Hemisulfate (taken as a tablet) and Ruzasvir (taken as a capsule). Both are antiviral medications designed to fight the virus in the body. The treatment lasts up to eight weeks, followed by an additional 12-week monitoring period to see if the virus remains undetectable in the blood.
Main inclusion criteria: Participants must be adults between 18 and 85 years old who are willing to provide written informed consent. Women of childbearing potential must agree to use effective birth control methods or abstain from heterosexual intercourse, and must have negative pregnancy tests at the study start and on the first day of treatment. Eligible participants must have never been treated with any approved or experimental direct-acting antiviral medications for hepatitis C before. They must have a documented medical history consistent with chronic hepatitis C, and their liver disease must be assessed as either having no cirrhosis (no severe liver scarring, classified as F0 to F3) or compensated cirrhosis (liver scarring present but liver still functions well, classified as F4).
Main exclusion criteria: People with any other significant liver disease apart from chronic hepatitis C are excluded, as are those who have had a liver transplant. Other exclusions include drug or alcohol abuse within the last 12 months, pregnancy or breastfeeding, severe heart problems, uncontrolled diabetes, any other serious medical condition that might interfere with the study, current participation in another clinical trial, severe allergic reaction history to any study medications, and history of cancer within the last five years (except certain types of skin cancer).
Trial focus: The study evaluates whether the combination of Bemnifosbuvir and Ruzasvir is safe and effective in treating chronic hepatitis C. Researchers will monitor participants throughout treatment and assess whether they achieve a sustained virologic response at 12 weeks post-treatment (SVR12), meaning the virus remains at undetectable levels in the blood. Regular follow-up visits will track health, treatment response, and safety.
Investigational drugs: Bemnifosbuvir works by interfering with the virus’s ability to multiply in the body, which may help reduce the viral load in the blood and improve liver health. Ruzasvir also stops the virus from replicating. The combination of these two medications is being evaluated to see if it can help patients achieve sustained undetectable virus levels even after treatment ends.
Summary
Both ongoing trials focus on evaluating antiviral combination treatments for chronic hepatitis C, with a particular emphasis on the Bemnifosbuvir-Ruzasvir combination. The trials are being conducted across several European countries, with Germany, Romania, and Spain hosting both studies, while France, Greece, and Poland participate in one trial each. Both studies target treatment-naïve patients (those who have never received direct-acting antiviral medications before) and accept participants with either no liver scarring or compensated cirrhosis. The age ranges differ between trials, with one accepting participants aged 18-70 and the other accepting a broader age range of 18-85. The primary goal across both trials is to determine whether these new treatment combinations can effectively eliminate the hepatitis C virus from the body, as measured by sustained undetectable virus levels after treatment completion.
