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

Phase 2CompletedNCT04019717

Atea Pharmaceuticals, Inc.10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Hepatitis C, Chronic Chronic Hepatitis C Hepatitis C Virus Infection HCV Infection

Interventions

AT-527DRUG

Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase

DaclatasvirDRUG

Inhibitor of HCV nonstructural protein 5A (NS5A)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Clinical Trial Site

Antwerp, Belgium

Clinical Trial Site

Phoenix, Mauritius

Clinical Trial Site

Chisinau, Moldova

Outcomes

Primary Outcomes

Proportion of subjects achieving sustained virologic response (SVR)

SVR defined as the HCV RNA \< lower limit of quantitation (LLOQ) at 12 weeks after end of treatment

Time frame: 12 weeks after end of treatment

Incidence of treatment-emergent adverse events

Time frame: Through 4 weeks after end of treatment

Data from ClinicalTrials.gov

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