Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
- Conditions
- Chronic Hepatitis C
- Interventions
- Drug: CDI-31244Drug: SOF/VEL
- Registration Number
- NCT03501550
- Lead Sponsor
- Cocrystal Pharma, Inc.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis
Key
Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CDI-31244 + SOF/VEL SOF/VEL CDI-31244 in combination with SOF/VEL CDI-31244 + SOF/VEL CDI-31244 CDI-31244 in combination with SOF/VEL
- Primary Outcome Measures
Name Time Method Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment post-treatment Week 12 SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment
Number of Subjects With Treatment Emergent Adverse Events Day 1 to Day 72 The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
- Secondary Outcome Measures
Name Time Method Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy post-treatment Week 24 SVR (sustained virologic response) 24 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 24 weeks after treatment
Trial Locations
- Locations (1)
Institute of Human Virology University of Maryland
🇺🇸Baltimore, Maryland, United States