BridgeMD
STUDY TO EVALUATE THE SAFETY AND EFFICACY OF BEMNIFOSBUVIR AND RUZASVIR IN PATIENTS WITH CHRONIC HEPATITIS C VIRUS INFECTION
EU CTIS ID: 2023-504566-28-00
What this study is testing
To evaluate the safety and tolerability of BEM + RZR. To evaluate the efficacy of BEM + RZR as assessed by the proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12).
- Therapeutic exploratory (Phase II)
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
- Willing and able to provide written informed consent
- Male or female subjects between ≥ 18 years of age (or the legal age of consent per local regulations) and ≤ 85 years of age
- Female subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to the use of an acceptable effective contraception
- Females of childbearing potential must have a negative pregnancy test at Screening and at Day 1 prior to dosing
- Subjects must be direct-acting antiviral (DAA)-treatment-naïve, defined as never exposed to an approved or experimental DAA for HCV
- Documented medical history compatible with chronic HCV
You likely can't join if
- Female subject is pregnant or breastfeeding
- 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
- Co-infected with hepatitis B virus (HBV; positive for hepatitis B surface antigen [HBsAg]) and/or human immunodeficiency virus (HIV)
- Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
- Prior exposure to any HCV DAA
- Use of other investigational drugs within 30 days of dosing or plans to enroll in another clinical trial of an investigational agent while participating in the present study
See the full eligibility criteria
- Willing and able to provide written informed consent
- Male or female subjects between ≥ 18 years of age (or the legal age of consent per local regulations) and ≤ 85 years of age
- Female subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to the use of an acceptable effective contraception
- Females of childbearing potential must have a negative pregnancy test at Screening and at Day 1 prior to dosing
- Subjects must be direct-acting antiviral (DAA)-treatment-naïve, defined as never exposed to an approved or experimental DAA for HCV
- Documented medical history compatible with chronic HCV
- Liver disease staging assessment as follows: - Absence of cirrhosis (F0 to F3); - Compensated cirrhosis (F4)
- Female subject is pregnant or breastfeeding
- 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
- Co-infected with hepatitis B virus (HBV; positive for hepatitis B surface antigen [HBsAg]) and/or human immunodeficiency virus (HIV)
- Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
- Prior exposure to any HCV DAA
- Use of other investigational drugs within 30 days of dosing or plans to enroll in another clinical trial of an investigational agent while participating in the present study
- Subject with known allergy to the study medications or any of their components
- History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
- Cirrhotic and has a Child-Pugh score >6, corresponding to a Child-Pugh Class B or C
- History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
The study team makes the final eligibility decision.
Where it's taking place
- Philippines
- South Africa
- Singapore
- Brazil
- Thailand
- Saudi Arabia
- Korea, Republic of
- Mauritius
- Malaysia
- Canada
- Egypt
- Australia
- Turkey
- India
- Pakistan
- Vietnam
- Indonesia
- Moldova, Republic of
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 Philippines; South Africa; Singapore; Brazil; Thailand; Saudi Arabia and 12 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.