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

April 26, 2021 updated by: Cocrystal Pharma, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Institute of Human Virology University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CDI-31244 + SOF/VEL
CDI-31244 in combination with SOF/VEL
Drug: CDI-31244
investigational drug
Other Names:
  • CDI-31244 (non-nucleoside inhibitor or NNI)
Drug: SOF/VEL
sofosbuvir and velpatasvir fixed dose combination
Other Names:
  • Epclusa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Treatment Emergent Adverse Events
Time Frame: Day 1 to Day 72
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
Time Frame: post-treatment Week 12
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
Time Frame: post-treatment Week 24
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cocrystal Pharma, Inc.

Investigators

  • Principal Investigator: Joel Chua, MD, Institute of Human Virology, University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 26, 2018

Primary Completion (ACTUAL)

January 8, 2019

Study Completion (ACTUAL)

June 7, 2019

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDI-31244-P2-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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