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

Primary Purpose

Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AT-527
Daclatasvir
Sponsored by
Atea Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

8 weeks

12 weeks

Arm Description

Outcomes

Primary Outcome Measures

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
Incidence of treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
July 11, 2019
Last Updated
May 1, 2020
Sponsor
Atea Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04019717
Brief Title
Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection
Official Title
A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination With Daclatasvir in Subjects With Chronic HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
January 29, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atea Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection, HCV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will receive 8 or 12 weeks of treatment, based on treatment response.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8 weeks
Arm Type
Experimental
Arm Title
12 weeks
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AT-527
Intervention Description
Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Intervention Description
Inhibitor of HCV nonstructural protein 5A (NS5A)
Primary Outcome Measure Information:
Title
Proportion of subjects achieving sustained virologic response (SVR)
Description
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
Title
Incidence of treatment-emergent adverse events
Time Frame
Through 4 weeks after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Jian Zhou, PhD
Organizational Affiliation
Atea Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Antwerp
Country
Belgium
Facility Name
Clinical Trial Site
City
Phoenix
Country
Mauritius
Facility Name
Clinical Trial Site
City
Chisinau
Country
Moldova, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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