BridgeMD
A Phase 3 Trial Comparing Whether BEM/RZR is Similar to SOF/VEL in Patients with Hepatitis C Virus Infection
EU CTIS ID: 2025-521096-31-00
What this study is testing
To evaluate the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Use of adequate contraception for females of childbearing potential.
- Must be direct-acting antiviral (DAA)-treatment naïve (never exposed to an approved or experimental DAA for HCV).
- Documented medical history compatible with chronic HCV.
- Either no liver cirrhosis or with compensated liver cirrhosis.
- If HIV-1 positive, must meet the following 2 criteria: 1. Antiretroviral (ARV) regimen for > 8 weeks prior to screening visit, with CD4 T-cell count > 200 cells/mm3 and plasma HIV-1RNA level < LLOQ 2. Suitable ARV treatment and not taking any contraindicated medications.
You likely can't join if
- Pregnant or breastfeeding.
- Co-infected with hepatitis B virus.
- Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator.
- Requirement of any prohibited medications.
- Use of other investigational drugs within 30 days of dosing.
- History or signs of decompensated liver disease (decompensated cirrhosis).
See the full eligibility criteria
- Use of adequate contraception for females of childbearing potential.
- Must be direct-acting antiviral (DAA)-treatment naïve (never exposed to an approved or experimental DAA for HCV).
- Documented medical history compatible with chronic HCV.
- Either no liver cirrhosis or with compensated liver cirrhosis.
- If HIV-1 positive, must meet the following 2 criteria: 1. Antiretroviral (ARV) regimen for > 8 weeks prior to screening visit, with CD4 T-cell count > 200 cells/mm3 and plasma HIV-1RNA level < LLOQ 2. Suitable ARV treatment and not taking any contraindicated medications.
- Pregnant or breastfeeding.
- Co-infected with hepatitis B virus.
- Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator.
- Requirement of any prohibited medications.
- Use of other investigational drugs within 30 days of dosing.
- History or signs of decompensated liver disease (decompensated cirrhosis).
- History of hepatocellular carcinoma (HCC).
- Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
The study team makes the final eligibility decision.
Where it's taking place
- Moldova, Republic of
- Egypt
- Thailand
- Turkey
- Pakistan
- Korea, Republic of
- Vietnam
- Malaysia
- South Africa
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moldova, Republic of; Egypt; Thailand; Turkey; Pakistan; Korea, Republic of and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.