Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04019717
Recruitment Status : Completed
First Posted : July 15, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Hepatitis C Hepatitis C, Chronic Chronic Hepatitis C Hepatitis C Virus Infection HCV Infection Drug: AT-527 Drug: Daclatasvir Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will receive 8 or 12 weeks of treatment, based on treatment response.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination With Daclatasvir in Subjects With Chronic HCV Infection
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : January 29, 2020
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
Drug Information available for: Daclatasvir

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)




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019717


Locations
Layout table for location information
Belgium
Clinical Trial Site
Antwerp, Belgium
Mauritius
Clinical Trial Site
Phoenix, Mauritius
Moldova, Republic of
Clinical Trial Site
Chisinau, Moldova, Republic of
Sponsors and Collaborators
Atea Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Xiao-Jian Zhou, PhD Atea Pharmaceuticals, Inc.
Layout table for additonal information
Responsible Party: Atea Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04019717    
Other Study ID Numbers: AT-01B-002
2019-001431-31 ( EudraCT Number )
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
Hepatitis, Chronic