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Bemnifosbuvir + Ruzasvir for Chronic Hepatitis C
Study Summary
This trial tests a new medicine for chronic hepatitis C to see if it's safe and effective.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I agree to not have sex or use effective birth control.I have a history of chronic hepatitis C.I am co-infected with hepatitis B and/or HIV.I have been treated with drugs for hepatitis C before.I have or might have liver cancer.I am between 18 and 85 years old.I have taken a pregnancy test and it was negative.I am currently pregnant or breastfeeding.I have severe liver problems, like fluid in the abdomen or bleeding veins in my stomach.My liver disease is not severe and does not include decompensated cirrhosis.My liver disease is severe, with a Child-Pugh score over 6.I have never been treated with drugs specifically for hepatitis C.
- Group 1: Bemnifosbuvir and Ruzasvir
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many facilities are carrying out this research experiment?
"This clinical trial is running from four separate sites in Constanţa, Craiova, and Bucuresti as well as an additional 4 locations. It would be prudent for potential participants to select the clinic nearest to them so they can conserve energy on any necessary transportation."
Does this experimental research allow individuals over forty to participate?
"This clinical trial is accepting adult participants ranging from 18 to 85 years of age."
To what extent do Bemnifosbuvir and Ruzasvir present risks for individuals?
"Our team at Power has judged the safety of Bemnifosbuvir and Ruzasvir to be a 2, as this is only a Phase 2 trial with evidence backing its security but not yet its efficacy."
Are new participants being enrolled in this investigation?
"Affirmative. According to the information on clinicaltrials.gov, this research project is actively enrolling patients and has been since its posting date of May 30th 2023; there have also been recent updates as recently as August 1st 2023. The study requires 280 participants from four different medical locations."
How many study participants are involved in this clinical experimentation?
"Yes, the data posted on clinicaltrials.gov confirms this investigation is actively recruiting patients which began on May 30th 2023 and was recently refreshed on August 1st 2023. This trial requires 280 participants to be recruited from 4 separate sites."
What are the qualifications to take part in this research study?
"This clinical trial is seeking 280 candidates with hepatitis c, aged 18-85. To be eligible for inclusion in the study, participants must fulfil additional criteria such as providing written informed consent and agreeing to abstain from heterosexual intercourse or use effective contraception if female of childbearing potential. Additionally, suitable applicants should have never been exposed to approved/experimental direct-acting antivirals (DAAs) and present a documented medical history compatible with chronic HCV alongside an absence of cirrhosis (F0 - F3), or compensated cirrhosis (F4)."
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