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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019717
• Other study ID #: AT-01B-002
• Secondary ID: 2019-001431-31
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2019
• Est. completion date: March 23, 2020

Study information

• Verified date: May 2020
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 23, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Communicable Diseases
• HCV Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Hepatitis C, Chronic
• Infection
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	Clinical Trial Site	Antwerp
Mauritius	Clinical Trial Site	Phoenix
Moldova, Republic of	Clinical Trial Site	Chisinau

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Belgium,  Mauritius,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of treatment-emergent adverse events		Through 4 weeks after end of treatment