Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection
Phase 2
Completed
- Conditions
- Hepatitis CHepatitis C, ChronicChronic Hepatitis CHepatitis C Virus InfectionHCV Infection
- Interventions
- Registration Number
- NCT04019717
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 8 weeks AT-527 - 8 weeks Daclatasvir - 12 weeks AT-527 - 12 weeks Daclatasvir -
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving sustained virologic response (SVR) 12 weeks after end of treatment SVR defined as the HCV RNA \< lower limit of quantitation (LLOQ) at 12 weeks after end of treatment
Incidence of treatment-emergent adverse events Through 4 weeks after end of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trial Site
🇲🇩Chisinau, Moldova, Republic of
Clinical Trial Site🇲🇩Chisinau, Moldova, Republic of