Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection

NCT04019717 — Phase 2, Completed, 10 participants, Atea Pharmaceuticals, Inc.

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A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination With Daclatasvir in Subjects With Chronic HCV Infection

Registry	NCT04019717
Status	Completed
Phase	Phase 2
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	10 (Actual)
Sponsor	Atea Pharmaceuticals, Inc. (Industry)
Conditions	Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection, HCV Infection
Interventions	AT-527, Daclatasvir (Drug)
Dates	start 2019-06-20, primary completion 2020-01-29, completion 2020-03-23, first posted 2019-07-15, last updated 2020-05-04
Locations	3 sites in Belgium, Mauritius, Moldova

-Summary

The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.

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+Arms and interventions

Arm	Type	Interventions	Description
8 weeks	Experimental	Drug: AT-527; Drug: Daclatasvir
12 weeks	Experimental	Drug: AT-527; Drug: Daclatasvir

AT-527 (Drug): Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
Daclatasvir (Drug): Inhibitor of HCV nonstructural protein 5A (NS5A)

+Outcome measures

Primary outcomes

Proportion of subjects achieving sustained virologic response (SVR) [12 weeks after end of treatment]: SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment
Incidence of treatment-emergent adverse events [Through 4 weeks after end of treatment]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Body mass index (BMI) of 18-35 kg/m2
* Must agree to use protocol-specified methods of contraception
* Negative pregnancy test
* HCV genotype 1
* Documented history compatible with chronic hepatitis C
* HCV RNA ≥ 10,000 IU/mL at Screening.
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus or HIV
* Abuse of alcohol or drugs
* Prior exposure to any HCV NS5A inhibitor
* Cirrhosis
* Use of other investigational drugs within 30 days of dosing
* Other clinically significant medical conditions or contraindications to daclatasvir

+Locations (3)

Facility	City	Country
Clinical Trial Site	Antwerp	Belgium
Clinical Trial Site	Phoenix	Mauritius
Clinical Trial Site	Chisinau	Moldova

+Investigators

Xiao-Jian Zhou, PhD, Study director, Atea Pharmaceuticals, Inc.

+Funding

NIH grants: 2019