Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection
The study is open label and has one treatment group. Eligible HCV GT1 subjects will self administer orally 400 mg of CDI-31244 and fixed dose combination of sofosbuvir and velpatasvir for 14 days. After 14 days the subjects will continue the treatment for another 4 weeks on the fixed dose combination sofosbuvir and velpatasvir. The subjects will be followed up until 24 weeks after the last dose of sofosbuvir and velpatasvir to determine if sustained virologic response at 12 (SVR12) and 24 (SVR24) weeks after treatment have been achieved.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Institute of Human Virology University of Maryland
Baltimore, Maryland, United States
Number of Subjects With Treatment Emergent Adverse Events
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
Time frame: Day 1 to Day 72
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment
Time frame: post-treatment Week 12
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy
SVR (sustained virologic response) 24 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 24 weeks after treatment
Time frame: post-treatment Week 24
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