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

Atea Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic; Hepatitis C; HCV Infection; Hepatitis C Virus Infection; Chronic Hepatitis C

Treatments: Drug: AT-527; Drug: Daclatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT04019717

2019-001431-31 (EudraCT Number)

AT-01B-002

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

8 weeks

Experimental group

Treatment:

Drug: AT-527

Drug: Daclatasvir

12 weeks

Experimental group

Treatment:

Drug: AT-527

Drug: Daclatasvir