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A Phase 2, Open-Label Study to Assess the Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects with Chronic Hepatitis C Virus (HCV) Infection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504566-28-00
Acronym
AT-01B-004
Enrollment
39
Registered
2023-07-26
Start date
2023-05-19
Completion date
2025-01-28
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Virus (HCV) Infection

Brief summary

The primary efficacy endpoint is SVR12. The proportion of subjects achieving SVR12 with two-sided 95% CIs using the Wilson score method will be presented. Reasons for failure to achieve SVR12 will be summarized.

Detailed description

The proportion of subjects in the PP population experiencing virological failure (either on-treatment or post-treatment relapse by 12 weeks post treatment) will be estimated and presented with 95% CIs., The proportion of subjects in the PP population achieving SVR24 will be analyzed using the same method as SVR12.

Interventions

Sponsors

Atea Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint is SVR12. The proportion of subjects achieving SVR12 with two-sided 95% CIs using the Wilson score method will be presented. Reasons for failure to achieve SVR12 will be summarized.

Secondary

MeasureTime frame
The proportion of subjects in the PP population experiencing virological failure (either on-treatment or post-treatment relapse by 12 weeks post treatment) will be estimated and presented with 95% CIs., The proportion of subjects in the PP population achieving SVR24 will be analyzed using the same method as SVR12.

Countries

Germany, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026