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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501550
• Other study ID #: CDI-31244-P2-001
• Status: Completed
• Phase: Phase 2
• Start date: June 26, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: April 2021
• Source: Cocrystal Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 7, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• CDI-31244
investigational drug
• SOF/VEL
sofosbuvir and velpatasvir fixed dose combination

Locations

Country	Name	City	State
United States	Institute of Human Virology University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Cocrystal Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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