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

May 1, 2020 updated by: Atea Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 8 weeks
Drug: AT-527
Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
Drug: Daclatasvir
Inhibitor of HCV nonstructural protein 5A (NS5A)
Experimental: 12 weeks
Drug: AT-527
Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
Drug: Daclatasvir
Inhibitor of HCV nonstructural protein 5A (NS5A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving sustained virologic response (SVR)
Time Frame: 12 weeks after end of treatment
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
Time Frame: Through 4 weeks after end of treatment
Through 4 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2019

Primary Completion (Actual)

January 29, 2020

Study Completion (Actual)

March 23, 2020

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-01B-002
  • 2019-001431-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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