Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
200 mg oral capsule once daily
400 mg oral capsule once daily
800 mg oral capsule once daily
Clinical Trial Site
Los Angeles, California, United States
Clinical Trial Site
Los Angeles, California, United States
Segment 1: Safety
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: 4 weeks
Segment 1: Rapid Viral Response At Week 4 (RVR4)
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus \[HCV\] ribonucleic acid (RNA) less than or equal to the limit of quantitation \[LOQ\] at the Week 4 visit).
Time frame: 4 weeks
Segment 2: Safety
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: 12 weeks
Segment 2: Complete Early Virologic Response (cEVR)
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
Time frame: Week 12
Segment 1: cEVR
For Segment 1, the percentage of participants in the virology population who achieved cEVR, defined as undetectable HCV RNA at Week 12.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Powder in capsule once daily
180 micrograms (ug) once a week by subcutaneous injection
400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily
Clinical Trial Site
San Francisco, California, United States
Clinical Trial Site
Bradenton, Florida, United States
Clinical Trial Site
Orlando, Florida, United States
Clinical Trial Site
Chicago, Illinois, United States
Clinical Trial Site
Overland Park, Kansas, United States
Clinical Trial Site
St Louis, Missouri, United States
Clinical Trial Site
Las Vegas, Nevada, United States
Clinical Trial Site
New York, New York, United States
...and 8 more locations
Segment 2: RVR4
For Segment 2, the percentage of participants in the virology population who achieved RVR4, defined as HCV RNA less than or equal to the LOQ at the Week 4 visit.
Time frame: 4 weeks
Segment 1 And Segment 2: End Of Treatment Response
The percentage of virology population participants who were reported as undetectable HCV RNA at the completion of treatment.
Time frame: Week 48 (Segment 1); Week 24 (Segment 2)
Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)
The percentage of virology population participants who achieved sustained virologic response (SVR), defined as HCV RNA less than the LOQ, at 12 weeks (3 months) post-dosing.
Time frame: 3 months post-dosing
Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)
The percentage of virology population participants who achieved SVR, defined as HCV RNA less than the LOQ, 6 months post-dosing.
Time frame: 6 months post-dosing
Segment 1 And Segment 2: HCV RNA Change From Baseline
The mean change from baseline in log10 HCV RNA level by visit for the virology population
Time frame: Week 4
Segment 1 And Segment 2: HCV RNA Change From Baseline
Change from baseline in log10 HCV RNA level by visit.
Time frame: Week 12