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

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What is this study about?

This study focuses on treating people with Chronic Hepatitis C Virus Infection, a long-term liver condition caused by the hepatitis C virus. The study compares two different combination treatments: Bemnifosbuvir-Ruzasvir (also known as BEM/RZR) and Sofosbuvir-Velpatasvir (also known as SOF/VEL). Both treatments are taken as tablets by mouth.

The purpose is to determine if BEM/RZR treatment, given once daily for either 8 or 12 weeks, works as well as SOF/VEL treatment, which is given once daily for 12 weeks. These medications work by directly targeting the virus that causes the infection.

During the study, participants will receive one of these treatments and will have their virus levels monitored through blood tests. The study will track how well the medications clear the virus from the body and whether the infection returns after treatment ends. The total duration of monitoring for each participant extends to 24 weeks to ensure long-term effectiveness of the treatment.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: BEM/RZR (bemnifosbuvir/ruzasvir) tablets taken once daily for either 8 or 12 weeks

Group 2: SOF/VEL (sofosbuvir/velpatasvir) tablets taken once daily for 12 weeks

2 Treatment period

Take the assigned medication orally once daily according to your group assignment

The treatment period will last either 8 or 12 weeks depending on your assigned group

Regular blood tests will be performed to measure HCV RNA (hepatitis C virus levels) in your blood

3 Post-treatment follow-up – Week 12

Blood tests will be conducted 12 weeks after your last dose of study medication

These tests will check if the virus levels remain below detectable limits

4 Final evaluation – Week 24

Final blood tests will be performed at week 24 of the study

This test will determine if the HCV RNA remains below detectable limits

This marks the primary evaluation point of the treatment’s effectiveness

5 Study completion

The study will conclude after the week 24 evaluation

Your participation will be complete after all required assessments are finished

Who Can Join the Study?

  • Must be between 18 and 70 years old
  • Both men and women can participate
  • Women who can become pregnant must use effective birth control methods
  • Must never have received treatment with direct-acting antiviral medications (medications that directly target the hepatitis C virus) before, whether approved or experimental
  • Must have medical records showing a history of long-term hepatitis C infection
  • Liver condition must be either:
    • Without cirrhosis (scarring of the liver), or
    • With compensated cirrhosis (early-stage liver scarring that doesn’t significantly impact liver function)
  • If HIV-positive, participants must:
    • Be on HIV medications (antiretroviral therapy) for more than 8 weeks before screening
    • Have a CD4 T-cell count (type of white blood cells) above 200 cells/mm3
    • Have undetectable HIV virus levels in blood
    • Be taking HIV medications that don’t interact with the study medication

Who Cannot Join the Study?

  • History of previous treatment with direct-acting antiviral agents (DAA medications) used to treat Hepatitis C
  • Co-infection with Hepatitis B virus or HIV
  • Presence of liver cirrhosis (severe scarring of the liver)
  • Current pregnancy or breastfeeding
  • Significant heart, kidney, or other organ disorders
  • Active substance abuse within the past 6 months
  • Current use of medications that could interact with study drugs
  • History of liver cancer or other types of cancer in the past 5 years
  • Abnormal blood test results showing poor liver or kidney function
  • Mental health conditions that could affect study participation
  • Unable to take oral medications
  • Participation in another clinical trial within the past 30 days
  • Known allergies to study medications or their components
  • Unstable medical conditions requiring frequent medication changes

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Gyncentrum Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
University General Hospital Of Heraklion Heraklion Greece
Eugastro GmbH Leipzig Germany
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu Balotesti Romania
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes Bucharest Romania
Centrul Medical Renasterea S.R.L. Craiova Romania
Hippokration Hospital Athens Greece
Evangelismos S.A. Athens Greece
ID Clinic Myslowice Poland
Institutul Clinic Fundeni Bucharest Romania
Med Polonia Sp. z o.o. Poznan Poland
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava Suceava Romania
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Centre Hospitalier Universitaire De Nice Nice France
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Spitalul Clinic Judetean De Urgenta Sibiu Sibiu Romania
Spitalul Clinic De Boli Infectioase Constanta Constanta Romania
Medrise Sp. z o.o. Lublin Poland
Hospital Universitario Virgen De La Victoria Malaga Spain
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi Iasi Romania
Gymzr Bckdtjr Kfdrsppre Ssb z oqzt Klodzko Poland
Uwweyhkjpy Mqbgyyd Crskry Hwvqhugebrbwfwkog Hamburg Germany
Haradhay Uvmiklmvjxvtw Mdttgtq Dn Vcxwdpqsuz Santander Spain
Gttdxgn Hcliwdwy ot Rafloj Amxwncu Pqqjcazwvr Rhodes Greece
Cwmzjx Hbihqdri Flb Idrktopfwx Dwgtsfkq Sss Csjzgwvi Plmwfzhnne Gqvqdm Galati Romania
Cfdyziq Mgkmdpsa w Łibdpdvb Lancut Poland
Hjgzuybt Pmpkkz Swat Vigo Spain
Ldujq Gcgpxwa Hqvdheuu Ok Avoytq Athens Greece
Gflfdy Ugzwvierbc Fjjuydaiv Frankfurt Germany
Huunfpqf Vtqn dcwkvjqc Barcelona Spain
Hegxkxgg Uiejfqerlskuhs Scpctolayi &pialcm Hneysmo dh Hcwdeatgles STRASBOURG, Alsace France
5 Wpoplkws Syxwych Khplwdhwh z Peldxwlxiuz Sfrla Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
31.10.2025
Germany Germany
Not recruiting
31.10.2025
Greece Greece
Not recruiting
31.10.2025
Poland Poland
Not recruiting
31.10.2025
Romania Romania
Not recruiting
31.10.2025
Spain Spain
Not recruiting
31.10.2025

Trial locations

Investigated drugs:

Bemnifosbuvir-Ruzasvir (BEM/RZR) is a combination medication used to treat chronic hepatitis C virus infection. It is an antiviral medication that works by stopping the virus from multiplying in the body.

Sofosbuvir-Velpatasvir (SOF/VEL) is also a combination antiviral medication used to treat chronic hepatitis C virus infection. It works by interfering with proteins needed by the hepatitis C virus to multiply, helping to clear the virus from the body.

Both medications are taken once daily and are designed to help eliminate the hepatitis C virus from the patient’s system. They represent different treatment options for people with chronic hepatitis C infection.

Investigated diseases:

Chronic Hepatitis C Virus (HCV) Infection – A viral infection that affects the liver, causing inflammation and damage over time. The infection begins with mild or no symptoms and develops gradually, often remaining unnoticed for years. The virus spreads through blood-to-blood contact and targets liver cells, where it multiplies and triggers an immune response. The ongoing inflammation can lead to scarring of liver tissue over time. Most people who get infected develop the chronic form of the disease, which means the infection persists for more than six months.

Trial ID:
2025-521096-31-00
Protocol code:
AT-01B-008
Trial Phase:
Therapeutic confirmatory (Phase III)

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