Study to Evaluate the Safety and Efficacy of Bemnifosbuvir and Ruzasvir in Patients with Chronic Hepatitis C Virus Infection

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Atea Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

19 May 2023 → 29 Jan 2025

Decision date (initial)

2024-04-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Atea Pharmaceuticals, Inc.

External identifiers

EU CT number

2023-504566-28-00

EudraCT number

2023-000160-54

ClinicalTrials.gov

NCT05904470

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Safety, Efficacy

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).

Secondary objectives 2

1. To evaluate the efficacy of BEM + RZR, as assessed by the proportion of subjects experiencing virologic failure (either on-treatment or posttreatment relapse [by 12 weeks post-treatment]).
2. To evaluate the efficacy of BEM + RZR as assessed by the proportion of subjects achieving sustained virologic response at 24 weeks posttreatment (SVR24).

Conditions and MedDRA coding

Chronic Hepatitis C Virus (HCV) Infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Willing and able to provide written informed consent
2. Male or female subjects between ≥ 18 years of age (or the legal age of consent per local regulations) and ≤ 85 years of age
3. Female subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to the use of an acceptable effective contraception
4. Females of childbearing potential must have a negative pregnancy test at Screening and at Day 1 prior to dosing
5. Subjects must be direct-acting antiviral (DAA)-treatment-naïve, defined as never exposed to an approved or experimental DAA for HCV
6. Documented medical history compatible with chronic HCV
7. Liver disease staging assessment as follows: - Absence of cirrhosis (F0 to F3); - Compensated cirrhosis (F4)

Exclusion criteria 10

1. Female subject is pregnant or breastfeeding
2. Co-infected with hepatitis B virus (HBV; positive for hepatitis B surface antigen [HBsAg]) and/or human immunodeficiency virus (HIV)
3. Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
4. Prior exposure to any HCV DAA
5. 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
6. Subject with known allergy to the study medications or any of their components
7. 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
8. Cirrhotic and has a Child-Pugh score >6, corresponding to a Child-Pugh Class B or C
9. History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
10. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 2

1. 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.
2. The proportion of subjects in the PP population achieving SVR24 will be analyzed using the same method as SVR12.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Atea Pharmaceuticals Inc.

Sponsor organisation

Atea Pharmaceuticals Inc.

Address

225 Franklin Street Suite 2100

City

Boston

Postcode

02110-2856

Country

United States

Scientific contact point

Organisation

Atea Pharmaceuticals Inc.

Contact name

Atea Clinical Trial Information

Public contact point

Organisation

Atea Pharmaceuticals Inc.

Contact name

Atea Clinical Trial Information

Third parties 10

Locations

3 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications