Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Open-Label Study to Assess the Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects with Chronic Hepatitis C Virus (HCV) Infection

This study is looking at two new medicines, called bemnifosbuvir and ruzasvir, for people who have a long-lasting liver infection called chronic Hepatitis C. It's a 'Phase 2' study, which means we're still in the early stages of testing these drugs to see if they're safe and effective. The main goal is to find out if the medicines can get rid of the Hepatitis C virus from a person's body completely, 12 weeks after they finish treatment. We'll also check if the virus stays away for 24 weeks, and understand why the treatment might not work for some people. This research helps us learn more about new ways to treat Hepatitis C.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Atea Pharmaceuticals Inc.

Enrolment target

Start

26 Jul 2023

Chronic Hepatitis C Virus (HCV) Infection

What is this study about?

This research study is focused on a health problem called chronic Hepatitis C. This is a type of infection that affects the liver and can last for a long time. The study is testing two experimental medicines, bemnifosbuvir and ruzasvir, to see if they can effectively treat this condition. Both medicines are designed to fight the Hepatitis C virus.

The main aim of the study is to see if these medicines can get rid of the Hepatitis C virus from a person's body completely. Doctors will check 12 weeks after treatment finishes to see if the virus is still detectable. This is called 'SVR12,' and it's a really important marker to show if the treatment has worked. They will also look at how many people still have the virus 24 weeks after treatment and try to understand why the treatment might not work for everyone.

Studies like this are crucial because they help us find new and better ways to treat serious conditions like Hepatitis C. By understanding how well these new medicines work and if they are safe, we can potentially offer more options to people living with this infection in the future.

Key takeaways

This study is testing two new medicines for chronic Hepatitis C.
The main goal is to see if the medicines can clear the virus from the body.
It's an early-stage study, checking for safety and how well the treatment works.
Participants must have chronic Hepatitis C and be aged 18 or over.
Regular visits and medical tests will be part of taking part.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you would need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate in this research. The study needs to include a variety of people to get a complete picture of how the medicines work.

Crucially, you must have been diagnosed with a long-lasting Hepatitis C virus (chronic Hepatitis C infection). The research is specifically for people with this condition, so other health issues might mean you can't join. The study team will check your full medical history to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with chronic Hepatitis C?
Are you able to attend regular clinic appointments?
Are you willing to take experimental medicines as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be given the experimental medicines, bemnifosbuvir and ruzasvir. These might be pills you take by mouth. You would need to attend regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various tests, like blood tests, to see how you are responding to the medicines and to check for any side effects. They would also monitor your general health.

There will be follow-up appointments after you finish taking the medicines to check if the Hepatitis C virus has gone and stayed away. The exact number of visits, tests, and the total length of time you'd be involved in the study would be explained in detail by the study team. You would need to commit to this schedule for the full duration of the research.

Potential risks and benefits

Taking part in this study could offer you access to new medicines for Hepatitis C that aren't yet widely available. These medicines might help clear the virus from your body. However, as with all medicines, there's always a chance of side effects or that the treatment might not work for you. The study doctors will carefully monitor you for any problems. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania
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Unverified
Germany
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Unverified
Spain

Common questions

What is chronic Hepatitis C?

It's a long-lasting infection caused by a virus that affects your liver. Over time, it can lead to serious liver damage.

What are bemnifosbuvir and ruzasvir?

These are the two experimental medicines being tested in this study. They are designed to fight the Hepatitis C virus.

What does 'Phase 2' mean?

It means the medicines are in an earlier stage of testing. Researchers are checking how safe they are and how well they work before they can be widely used.

What is SVR12?

SVR12 stands for 'Sustained Virologic Response at 12 weeks.' It means the Hepatitis C virus is no longer found in your blood 12 weeks after you finish treatment, which is a sign the treatment has worked.

Will I get paid to join?

The study information doesn't mention payment for participation, but you should ask the study team about any costs or reimbursements for travel.