A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05904470 |
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Recruitment Status :
Recruiting
First Posted : June 15, 2023
Last Update Posted : March 18, 2024
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Sponsor:
Atea Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.
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Brief Summary:
This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Hepatitis C Virus Hepatitis C, Chronic Hepatitis C Hepatic Cirrhosis HCV | Drug: Bemnifosbuvir Drug: Ruzasvir | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 280 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | May 30, 2023 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | September 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Bemnifosbuvir and Ruzasvir
Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules |
Drug: Bemnifosbuvir
550 mg administered orally once a day (QD) for 8 weeks
Other Name: AT-527 Drug: Ruzasvir 180 mg administered orally once a day (QD) for 8 weeks
Other Name: AT-038 |
Primary Outcome Measures :
- Proportion of subjects experiencing treatment-emergent adverse events [ Time Frame: Day 1 through 4 weeks after end of treatment ]
- Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12) [ Time Frame: Day 1 through12 weeks after end of treatment ] SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment ]
Secondary Outcome Measures :
- Proportion of subjects experiencing virologic failure [ Time Frame: Day 1 thru 12 weeks after end of treatment ]
- Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24) [ Time Frame: Day 1 thru 24 weeks after end of treatment ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion 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 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
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Liver disease staging assessment as follows:
- Absence of cirrhosis (F0 to F3)
- Compensated cirrhosis (F4)
Exclusion Criteria:
- Female subject is pregnant or breastfeeding
- 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05904470
Contacts
| Contact: Clinical Trials Administrator | 1(857)284-8891 | ateaclinicaltrials@ateapharma.com |
Locations
| Brazil | |
| Atea Study Site | Recruiting |
| Manaus, Amazonas, Brazil, 69040-000 | |
| Atea Study Site | Recruiting |
| Rio De Janeiro, Rio Do Janeiro, Brazil, 04037-030 | |
| Atea Study Site | Recruiting |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074 | |
| Atea Study Site | Recruiting |
| Porto Velho, Rondonia, Brazil, 78918-791 | |
| Atea Study Site | Recruiting |
| Boa Vista, Roraima, Brazil, 69304-015 | |
| Atea Study Site | Recruiting |
| Botucatu, Sao Paulo, Brazil, 18618-970 | |
| Atea Study Site | Recruiting |
| Ijuí, Sao Paulo, Brazil, 98700-000 | |
| Atea Study Site | Recruiting |
| Sorocaba, Sao Paulo, Brazil, 18052-210 | |
| Atea Study Site | Recruiting |
| São José Do Rio Preto, Sao Paulo, Brazil, 15090-000 | |
| Atea Study Site | Recruiting |
| São Paulo, Sao Paulo, Brazil, 04119-001 | |
| Atea Study Site | Recruiting |
| São Paulo, Sao Paulo, Brazil, 05403-000 | |
| Canada, British Columbia | |
| Atea Study Site | Recruiting |
| Vancouver, British Columbia, Canada, V6Z 2C7 | |
| Canada, Ontario | |
| Atea Study Site | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| India | |
| Atea Study Site | Recruiting |
| Rājkot, Gujarat, India, 360005 | |
| Atea Study Site | Recruiting |
| Sūrat, Gujarat, India, 395002 | |
| Atea Study Site | Recruiting |
| Belgaum, Karnataka, India, 590010 | |
| Atea Study Site | Recruiting |
| Nagpur, Maharashtra, India, 440010 | |
| Atea Study Site | Recruiting |
| Kolkata, West Bengal, India, 700020 | |
| Korea, Republic of | |
| Atea Study Site | Recruiting |
| Seoul, Gyeonggi, Korea, Republic of, 120-752 | |
| Atea Study Site | Recruiting |
| Yangsan, Gyeongsangnam, Korea, Republic of, 626-770 | |
| Atea Study Site | Recruiting |
| Busan, Korea, Republic of, 47392 | |
| Atea Study Site | Recruiting |
| Busan, Korea, Republic of, 49241 | |
| Atea Study Site | Recruiting |
| Seoul, Korea, Republic of, 5505 | |
| Atea Study Site | Recruiting |
| Seoul, Korea, Republic of, 6351 | |
| Mauritius | |
| Atea Study Site | Recruiting |
| Quatre Bornes, Mauritius, 72218 | |
| Moldova, Republic of | |
| Atea Study Site | Recruiting |
| Chisinau, Moldova, Republic of, 2025 | |
| Pakistan | |
| Atea Study Site | Recruiting |
| Karachi, Pakistan, 74800 | |
| Atea Study Site | Recruiting |
| Karachi, Pakistan, 75600 | |
| Philippines | |
| Atea Study Site | Recruiting |
| Iloilo City, Philippines, 5000 | |
| Atea Study Site | Recruiting |
| Mabalacat, Philippines, 2023 | |
| Romania | |
| Atea Study Site | Recruiting |
| Bucuresti, BUC, Romania, 022328 | |
| Atea Study Site | Recruiting |
| Bucuresti, BUC, Romania, 30303 | |
| Atea Study Site | Recruiting |
| Constanţa, CON, Romania, 900709 | |
| Atea Study Site | Recruiting |
| Craiova, DOL, Romania, 200073 | |
| Atea Study Site | Recruiting |
| Bucuresti, Romania, 21105 | |
| South Africa | |
| Atea Study Site | Recruiting |
| Bloemfontein, Free State, South Africa, 9301 | |
| Atea Study Site | Recruiting |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Atea Study Site | Recruiting |
| Randburg, Gauteng, South Africa, 2087 | |
| Atea Study Site | Recruiting |
| Somerset West, Western Cap, South Africa, 7130 | |
| Turkey | |
| Atea Study Site | Recruiting |
| Ankara, Turkey, 6100 | |
| Atea Study Site | Recruiting |
| Ankara, Turkey, 6230 | |
| Atea Study Site | Recruiting |
| Ankara, Turkey, 6800 | |
| Atea Study Site | Recruiting |
| Denizli, Turkey, 20070 | |
| Atea Study Site | Recruiting |
| Kayseri, Turkey, 38010 | |
Sponsors and Collaborators
Atea Pharmaceuticals, Inc.
| Responsible Party: | Atea Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT05904470 |
| Other Study ID Numbers: |
AT-01B-004 |
| First Posted: | June 15, 2023 Key Record Dates |
| Last Update Posted: | March 18, 2024 |
| Last Verified: | March 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
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Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Cirrhosis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Chronic Disease Disease Attributes Pathologic Processes Fibrosis Ruzasvir Antiviral Agents Anti-Infective Agents |