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Ruzasvir

Clinical trials are studying Ruzasvir in people with chronic hepatitis C virus (HCV) infection. These trials are looking at safety, tolerability, and how well Ruzasvir-based treatment works, including in combination with other antiviral drugs and compared with standard treatment.

Table of Contents

Clinical trials overview

These studies are testing Ruzasvir in people with chronic hepatitis C virus (HCV) infection.[1][2] The trials are looking at whether Ruzasvir-based treatment is safe, tolerable, and effective for this condition.[1]

Both trials are interventional studies, which means researchers give a study treatment and then measure the results.[1][2] The studies include a Phase 2 trial and a Phase 3 trial.[1][2]

Phase 2 study of Ruzasvir and bemnifosbuvir

The Phase 2 study, NCT05904470, was completed and included 249 participants with chronic HCV infection.[1] It studied Ruzasvir together with bemnifosbuvir, both taken by mouth.[1]

The study aimed to evaluate safety and tolerability, as well as how well the treatment worked.[1] This makes it an early study that helps show whether the treatment may be useful for people with hepatitis C.[1]

Phase 3 comparison study

The Phase 3 trial, 2025-521096-31-00, is authorised and plans to enroll 880 people with chronic HCV infection.[2] It compares a fixed-dose combination of bemnifosbuvir/Ruzasvir with sofosbuvir/velpatasvir.[2]

The study is designed to see whether the bemnifosbuvir/Ruzasvir treatment is similar to the comparison treatment.[2] The trial uses once-daily treatment for 8 or 12 weeks in the study arm and 12 weeks in the comparison arm.[2]

Outcomes and endpoints

The main result in the Phase 2 study is SVR12, which means sustained virologic response 12 weeks after treatment ends.[1] In simple terms, this checks how many people still have no detectable virus after treatment.[1]

The main result in the Phase 3 study is the proportion of people with HCV RNA below the lower limit of quantitation at study week 24.[2] This means the test looks for whether the virus level is so low that the lab test cannot measure it accurately.[2]

The Phase 2 study also summarized reasons why some people did not reach SVR12.[1] That kind of information helps researchers understand where treatment may fail and how future studies can improve.[1]

Who the trials are for

Both studies are for people with chronic hepatitis C virus infection.[1][2] The trial data do not list more detailed patient rules, such as age limits or other health requirements.[1][2]

  • The Phase 2 trial included people already living with chronic HCV infection and measured how they responded to the study treatment.[1]
  • The Phase 3 trial is larger and is comparing the study treatment with a standard treatment option in the same disease group.[2]

Key terms explained

Chronic hepatitis C virus infection means a long-lasting infection that can affect the liver over time.[1][2] Interventional study means the researchers give a treatment and watch what happens.[1][2]

Enrollment is the number of people planned or included in a study.[1][2] Authorised means the Phase 3 trial has been approved to move forward.[2]

Trial ID Phase Condition studied Status Enrollment
NCT05904470 Phase 2 Chronic Hepatitis C Virus (HCV) Infection Completed 249
2025-521096-31-00 Phase 3 Chronic Hepatitis C Virus (HCV) Infection Authorised 880

FAQ

  • What is being studied in clinical trials of Ruzasvir? The trials are studying Ruzasvir as part of treatment for chronic hepatitis C virus infection. They look at whether it helps lower or clear the virus and whether the treatment is safe and tolerable.
  • Who can join these Ruzasvir trials? The main target group is adults with chronic hepatitis C virus infection. Each study has its own rules for who can take part, such as the type of infection and other health details.
  • What trial phases are included? The available studies include Phase 2 and Phase 3 trials. Phase 2 studies usually look at early safety and how well the treatment works, while Phase 3 studies compare the treatment with another standard option in a larger group.
  • What outcomes are the trials measuring? One trial measures sustained virologic response at 12 weeks after treatment, called SVR12. Another measures whether hepatitis C virus RNA is below the lower limit of quantitation at study week 24, which means the virus is too low to measure accurately.
  • Are these trials testing Ruzasvir alone? No. The trials are testing Ruzasvir with other medicines, including bemnifosbuvir and a fixed-dose combination with bemnifosbuvir, and comparing one study treatment with sofosbuvir/velpatasvir.

Ongoing Clinical Trials on Ruzasvir

  • Comparing bemnifosbuvir-ruzasvir and sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in adult patients

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Poland Romania Spain

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

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Romania Spain

Glossary

  • Chronic hepatitis C virus (HCV) infection: A long-lasting infection caused by the hepatitis C virus. It can affect the liver for many years.
  • Interventional study: A clinical trial where researchers give a treatment and then watch what happens.
  • Phase 2: An early stage of testing that looks at safety and how well a treatment may work.
  • Phase 3: A later stage of testing in a larger group, often comparing a study treatment with a standard treatment.
  • Safety: How well a treatment is tolerated and whether it causes problems during the study.
  • Tolerability: How easy or hard it is for people to take the treatment without major issues.
  • Efficacy: How well a treatment works for the condition being studied.
  • Sustained virologic response at 12 weeks (SVR12): A result used in hepatitis C studies that means the virus is still not found 12 weeks after treatment ends.
  • HCV RNA: The genetic material of the hepatitis C virus. Measuring it helps show how much virus is in the body.
  • Lower limit of quantitation (LLOQ): The lowest level a test can measure accurately. If virus levels are below this, they are too small to measure well.
  • Fixed-dose combination (FDC): Two or more medicines made into one treatment product.
  • Enrollment: The number of people planned or included in a clinical trial.

References