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

NCT04019717 | Completed Phase 2

• 2 other identifiers: AT-01B-0022019-001431-31
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  12 weeks after end of treatment

• Incidence of treatment-emergent adverse events

  Through 4 weeks after end of treatment

Study Arms (2)

8 weeks

EXPERIMENTAL

Drug: AT-527; Drug: Daclatasvir

12 weeks

EXPERIMENTAL

Drug: AT-527; Drug: Daclatasvir

Interventions

AT-527 DRUG

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

12 weeks; 8 weeks

Daclatasvir DRUG

Inhibitor of HCV nonstructural protein 5A (NS5A)

12 weeks; 8 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (3)

Clinical Trial Site

Antwerp, Belgium

Location

Clinical Trial Site

Phoenix, Mauritius

Location

Clinical Trial Site

Chisinau, Moldova

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

AT-511; daclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiao-Jian Zhou, PhD

  Atea Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: June 20, 2019
• Primary Completion: January 29, 2020
• Study Completion: March 23, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-05

Locations

MO (1); MA (1); BE (1)