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VELPATASVIR

Clinical trials investigating VELPATASVIR are studying its use in people with chronic hepatitis C virus infection. The trial data focus on comparing treatment results, especially how well the study treatment lowers virus levels and how many patients respond. The main target population is adults with chronic HCV infection.

Table of Contents

Trial overview

This article is based on one Phase 3 interventional trial that includes VELPATASVIR as part of a comparison treatment for people with chronic hepatitis C virus infection.[1]

The study is titled as a comparison of whether BEM/RZR is similar to SOF/VEL in patients with hepatitis C virus infection.[1]

The condition being studied is chronic Hepatitis C Virus (HCV) infection.[1]

Who is being studied

The target population is people with chronic HCV infection.[1]

The trial data do not give extra details about age limits, sex, or other entry rules, so only the condition-based population can be described from the source information.[1]

Trial design and treatment comparison

This is an interventional study, which means researchers assign study treatment and then measure the results.[1]

The brief summary says the trial is evaluating the efficacy of BEM/RZR fixed dose combination given for 8 or 12 weeks once daily versus SOF/VEL given for 12 weeks once daily.[1]

SOF/VEL is the comparator treatment named in the source data, and VELPATASVIR appears as part of that comparison regimen.[1]

The trial is also described as comparing whether BEM/RZR is similar to SOF/VEL, which means the researchers want to see if the results are close enough to be considered comparable.[1]

Main endpoint and what it means

The main endpoint is the proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.[1]

In simple words, this measures how many people have virus levels so low that the test cannot measure them reliably at that time point.[1]

This endpoint is used to judge how effective the study treatment is at reducing the virus in the blood.[1]

Study status and size

The trial status is Authorised.[1]

The planned enrollment is 880 participants, which means the study is designed to include a large group of people.[1]

A larger trial can help researchers compare treatment results more reliably.[1]

Patient glossary for this study

  • HCV: short for hepatitis C virus, the virus that causes the infection being studied.[1]
  • RNA: the genetic material of the virus measured in blood tests.[1]
  • LLOQ: the lowest amount a test can measure with confidence.[1]
  • Once daily: taken one time each day.[1]
  • Fixed dose combination: two medicines combined into one treatment product.[1]
  • Comparator: the treatment used for comparison in a trial.[1]
Trial ID Phase Condition studied Status Enrollment
2025-521096-31-00 Phase 3 Chronic Hepatitis C Virus (HCV) Infection Authorised 880

FAQ

  • What clinical trial is studying VELPATASVIR? The trial is a Phase 3 study in people with chronic hepatitis C virus infection. It compares a treatment containing VELPATASVIR with another study treatment.
  • What condition is being studied? The condition is chronic hepatitis C virus (HCV) infection. This means the virus has been present for a long time and needs treatment.
  • What is the main goal of the trial? The main goal is to see how well treatment works by measuring the number of people whose HCV RNA falls below the lower limit of quantitation at study week 24. HCV RNA is the amount of virus in the blood.
  • What phase is the trial? This is a Phase 3 trial. Phase 3 studies usually compare treatments in a larger group of patients to check how well they work.
  • How many people are planned for the study? The trial plans to enroll 880 people. This larger number helps researchers compare the treatments more reliably.

Ongoing Clinical Trials on VELPATASVIR

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

    Not recruiting

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

Glossary

  • Chronic hepatitis C virus (HCV) infection: A long-lasting infection caused by the hepatitis C virus. It can affect the liver over time.
  • Phase 3: A late stage of clinical research where a treatment is tested in a larger group of people to compare how well it works.
  • Interventional study: A study where researchers give a treatment and measure the results.
  • Fixed dose combination (FDC): A treatment that combines two medicines in one product.
  • Oral: Taken by mouth.
  • HCV RNA: The amount of hepatitis C virus genetic material in the blood. It is used to see how much virus is still present.
  • Lower limit of quantitation (LLOQ): The lowest amount of virus a test can measure reliably.
  • Study week 24: The point 24 weeks after the study starts or after a treatment schedule begins, depending on the trial design.
  • Efficacy: How well a treatment works.
  • Enrollment: The number of people planned to join the study.

References