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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04019717

Enrollment

Registered

2019-07-15

Start date

2019-06-20

Completion date

2020-03-23

Last updated

2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

DRUGAT-527

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

DRUGDaclatasvir

Inhibitor of HCV nonstructural protein 5A (NS5A)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Subjects will receive 8 or 12 weeks of treatment, based on treatment response.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

Belgium, Mauritius, Moldova

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026