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
1 other identifier
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2019
CompletedResults Posted
Study results publicly available
April 28, 2021
CompletedApril 28, 2021
April 1, 2021
7 months
April 9, 2018
March 31, 2021
April 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy
post-treatment Week 24
Study Arms (1)
CDI-31244 + SOF/VEL
EXPERIMENTALCDI-31244 in combination with SOF/VEL
Interventions
Eligibility Criteria
You may qualify if:
- Documented chronic HCV GT 1 infection; Serum HCV RNA \>1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis
You may not qualify if:
- Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Human Virology University of Maryland
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Luz Pascual
- Organization
- Cocrystal Pharma Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Chua, MD
Institute of Human Virology, University of Maryland, Baltimore
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2018
First Posted
April 18, 2018
Study Start
June 26, 2018
Primary Completion
January 8, 2019
Study Completion
June 7, 2019
Last Updated
April 28, 2021
Results First Posted
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share