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Anti-viral

Bemnifosbuvir + Ruzasvir for Chronic Hepatitis C

Phase 2
Recruiting
Research Sponsored by Atea Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through 4 weeks after end of treatment
Awards & highlights

Study Summary

This trial tests a new medicine for chronic hepatitis C to see if it's safe and effective.

Who is the study for?
This trial is for adults aged 18-85 with chronic Hepatitis C who haven't been treated with direct-acting antiviral drugs. They must not have severe liver damage or cirrhosis, no history of liver cancer, and can't be pregnant or breastfeeding. Participants should agree to use effective contraception if applicable.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of two medications, Bemnifosbuvir (BEM) and Ruzasvir (RZR), in treating chronic Hepatitis C virus infection. It's an open-label study where all participants know which treatment they're receiving.See study design
What are the potential side effects?
Potential side effects from BEM and RZR may include typical drug reactions like nausea, headache, fatigue, possible allergic reactions to ingredients in the medication, as well as any specific risks associated with antiviral treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through 4 weeks after end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through 4 weeks after end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12)
Proportion of subjects experiencing treatment-emergent adverse events
Secondary outcome measures
Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24)
Proportion of subjects experiencing virologic failure

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bemnifosbuvir and RuzasvirExperimental Treatment2 Interventions
Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruzasvir
2016
Completed Phase 2
~910

Find a Location

Who is running the clinical trial?

Atea Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
3,537 Total Patients Enrolled
3 Trials studying Hepatitis C
98 Patients Enrolled for Hepatitis C

Media Library

Bemnifosbuvir (Anti-viral) Clinical Trial Eligibility Overview. Trial Name: NCT05904470 — Phase 2
Hepatitis C Research Study Groups: Bemnifosbuvir and Ruzasvir
Hepatitis C Clinical Trial 2023: Bemnifosbuvir Highlights & Side Effects. Trial Name: NCT05904470 — Phase 2
Bemnifosbuvir (Anti-viral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05904470 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
~23 spots leftby Jun 2024