Status:
COMPLETED
Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection
Lead Sponsor:
Atea Pharmaceuticals, Inc.
Conditions:
Hepatitis C
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04019717
Start Date
June 20 2019
End Date
March 23 2020
Last Update
May 4 2020
Active Locations (3)
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1
Clinical Trial Site
Antwerp, Belgium
2
Clinical Trial Site
Phoenix, Mauritius
3
Clinical Trial Site
Chisinau, Moldova