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Completed

NCT Number: NCT04019717

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trial Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT-527

Drug

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

Daclatasvir

Drug

Inhibitor of HCV nonstructural protein 5A (NS5A)

Primary outcomes

  1. 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

  2. Incidence of treatment-emergent adverse events

    Time frame: Through 4 weeks after end of treatment

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2019
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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