Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection
NCT ID: NCT04019717
Last Updated: 2020-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2019-06-20
2020-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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8 weeks
AT-527
Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
Daclatasvir
Inhibitor of HCV nonstructural protein 5A (NS5A)
12 weeks
AT-527
Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
Daclatasvir
Inhibitor of HCV nonstructural protein 5A (NS5A)
Interventions
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AT-527
Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
Daclatasvir
Inhibitor of HCV nonstructural protein 5A (NS5A)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiao-Jian Zhou, PhD
Role: STUDY_DIRECTOR
Atea Pharmaceuticals, Inc.
Locations
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Clinical Trial Site
Antwerp, , Belgium
Clinical Trial Site
Phoenix, , Mauritius
Clinical Trial Site
Chisinau, , Moldova
Countries
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Other Identifiers
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2019-001431-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AT-01B-002
Identifier Type: -
Identifier Source: org_study_id
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