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Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Drug: CDI-31244
Drug: 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
Inclusion Criteria

Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis

Key

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Exclusion Criteria

Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
CDI-31244 + SOF/VELSOF/VELCDI-31244 in combination with SOF/VEL
CDI-31244 + SOF/VELCDI-31244CDI-31244 in combination with SOF/VEL
Primary Outcome Measures
NameTimeMethod
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatmentpost-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 EventsDay 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
NameTimeMethod
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapypost-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

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