NCT03501550

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cocrystal Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	CDI-31244	investigational drug
DRUG	SOF/VEL	sofosbuvir and velpatasvir fixed dose combination

Timeline

• Start date: 2018-06-26
• Primary completion: 2019-01-08
• Completion: 2019-06-07
• First posted: 2018-04-18
• Last updated: 2021-04-28
• Results posted: 2021-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study