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RecruitingPHASE3INTERVENTIONAL

C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV

This study, called C-Forward, is testing two different medication combinations for chronic hepatitis C virus (HCV) infection. One combination is Bemnifosbuvir-Ruzasvir (BEM/RZR), and the other is Sofosbuvir-Velpatasvir (SOF/VEL). Researchers want to find out which treatment works best at clearing the virus and if they are safe for people to use. It's designed for adults aged 18 to 85 who have chronic hepatitis C and haven't previously been treated with direct-acting antiviral medicines. Participants should also generally have good liver health or only mild liver damage. This is a Phase 3 study, meaning it's a large trial to confirm the treatment's effectiveness and safety.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Atea Pharmaceuticals, Inc.
Enrolment target
880
Start
02 Jun 2025
Estimated completion
01 Mar 2027

What is this study about?

You might be reading this because you, or someone you know, has chronic hepatitis C. This is a long-lasting infection caused by a virus that affects your liver. The C-Forward study is looking at new ways to treat this condition.

The study is comparing two different combinations of medicines: one called BEM/RZR and another called SOF/VEL. Both are designed to fight the hepatitis C virus. The main goal is to see which combination is more effective at clearing the virus from the body and how safe each one is. These types of studies are really important because they help doctors understand the best ways to treat hepatitis C in the future, offering more options for patients.

This is a Phase 3 study, which means these treatments have already been tested in smaller groups. Now, they are being given to a larger group of people to confirm their benefits and safety. By taking part, you could contribute to medical science and help others who live with hepatitis C.

Key takeaways

  • This study compares two treatments for chronic hepatitis C: BEM/RZR and SOF/VEL.
  • It's for adults (18-85) who are new to direct-acting antiviral treatments for HCV.
  • Participants should have mild or no liver damage (compensated cirrhosis).
  • It's a Phase 3 study, meaning it's a large trial to confirm safety and effectiveness.
  • The goal is to find better treatment options for people with hepatitis C.
  • You can withdraw from the study at any time without penalty.

Who may be eligible?

The study is looking for adults aged between 18 and 85 years old. You should have chronic hepatitis C, which means you've had the infection for a long time. It's important that you haven't taken any direct-acting antiviral (DAA) medicines for hepatitis C before, as this study is for people new to these types of treatments.

Your liver health is also a key factor. You can either have no liver scarring (cirrhosis) or only mild scarring that isn't causing serious problems. If you also have HIV, your HIV should be well-controlled with your current medications, and you must meet specific blood test requirements.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you also have hepatitis B. The study also cannot include individuals with serious liver complications, such as severe liver scarring or liver cancer. If you are struggling with alcohol or drug use that might make it hard to stick to the study's plan, this might also exclude you.

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.

  1. Are you between 18 and 85 years old?
  2. Do you have chronic hepatitis C?
  3. Have you never taken modern hepatitis C antiviral medicines (DAAs) before?
  4. Do you not have severe liver disease (like severe scarring or liver cancer)?
  5. Are you not pregnant or breastfeeding?
  6. Do you not also have hepatitis B?
Answer every question to see your result.

What does participation involve?

Details about taking part in this specific study are not fully described here. However, typically in a clinical trial like this, you would have an initial screening visit to check if you're suitable. If you qualify, you'd begin the study treatment, which involves taking medication regularly, as instructed. You would have several follow-up visits to the clinic. These visits usually involve blood tests, physical examinations, and questions about how you're feeling and any side effects you might be experiencing. These visits help the doctors monitor your health and the effectiveness of the treatment. The total duration of your participation, including treatment and follow-up, would be clearly explained to you before you agree to join.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new or effective treatment for your hepatitis C under close medical supervision. You would also be playing an active role in advancing medical knowledge for others with the condition. However, there are potential risks, as with any medication. You might experience side effects, some of which could be unexpected or serious. The treatment might not work for you, or it could even affect your existing health conditions. All potential risks and benefits will be fully explained before you decide to join. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (106)

  • Atea Study Site
    Verified postcode
    Nice, France· Recruiting
  • Atea Study Site
    Verified postcode
    Strasbourg, France· Recruiting
  • Atea Study Site
    Verified postcode
    Clichy, France· Recruiting
  • Atea Study Site
    Verified postcode
    Montpellier, France· Recruiting
  • Atea Study Site
    Verified postcode
    Clermont-Ferrand, France· Recruiting
  • Atea Study Site
    Verified postcode
    Créteil, France· Recruiting
  • Atea Study Site
    Verified postcode
    Frankfurt am Main, Germany· Recruiting
  • Atea Study Site
    Verified postcode
    Leipzig, Germany· Recruiting
  • Atea Study Site
    Verified postcode
    Hamburg, Germany· Recruiting
  • Atea Study Site
    Verified postcode
    Alexandroupoli, Greece· Recruiting
  • Atea Study Site
    Verified postcode
    Athens, Greece· Recruiting
  • Atea Study Site
    Verified postcode
    Athens, Greece· Recruiting

Common questions

What is chronic hepatitis C?

Chronic hepatitis C is a long-lasting infection of the liver caused by the hepatitis C virus. Over time, it can lead to liver damage if not treated.

What kind of treatments are being tested?

The study is comparing two combinations of antiviral medicines, BEM/RZR and SOF/VEL, which are designed to target and clear the hepatitis C virus.

Who can join this study?

Adults aged 18-85 with chronic hepatitis C who haven't had previous modern antiviral treatments and generally have good liver health are considered.

Why is this study important?

It's important because it helps researchers find out which new treatments are most effective and safe for people with hepatitis C, potentially leading to better care in the future.

Will I have to pay to join?

No, you should not have to pay to participate in a clinical trial. All study-related medication and tests are typically provided free of charge by the study sponsors.

How to find out more

Clinical Trials Administrator

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subj…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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