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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-Label Phase 2a Study Evaluating the Safety and Efficacy of Combination Treatment With 2 Weeks of the Non-Nucleoside Inhibitor CDI 31244 Plus 6 Weeks of Sofosbuvir/Velpatasvir in Subjects With Chronic Hepatitis C Genotype 1 Infection

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: CDI-31244
* Drug: SOF/VEL


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis Key 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDI-31244 + SOF/VEL<br>CDI-31244 in combination with SOF/VEL | Drug: CDI-31244<br>* investigational drug<br>* Other names: CDI-31244 (non-nucleoside inhibitor or NNI);Drug: SOF/VEL<br>* sofosbuvir and velpatasvir fixed dose combination<br>* Other names: Epclusa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | post-treatment Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | post-treatment Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, GT1