Back to resultsStudy of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CDI-31244
SOF/VEL
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV, GT1
Eligibility Criteria
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
Sites / Locations
- Institute of Human Virology University of Maryland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CDI-31244 + SOF/VEL
Arm Description
CDI-31244 in combination with SOF/VEL
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03501550
Brief Title
Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
June 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cocrystal Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
HCV, GT1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDI-31244 + SOF/VEL
Arm Type
Experimental
Arm Description
CDI-31244 in combination with SOF/VEL
Intervention Type
Drug
Intervention Name(s)
CDI-31244
Other Intervention Name(s)
CDI-31244 (non-nucleoside inhibitor or NNI)
Intervention Description
investigational drug
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
Epclusa
Intervention Description
sofosbuvir and velpatasvir fixed dose combination
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment Emergent Adverse Events
Description
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
Time Frame
Day 1 to Day 72
Title
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
Description
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after treatment
Time Frame
post-treatment Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy
Description
SVR (sustained virologic response) 24 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 24 weeks after treatment
Time Frame
post-treatment Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Chua, MD
Organizational Affiliation
Institute of Human Virology, University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Human Virology University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
We'll reach out to this number within 24 hrs