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

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ClinicalTrials.gov Identifier: NCT03501550
Recruitment Status : Active, not recruiting
First Posted : April 18, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Cocrystal Pharma, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: CDI-31244 Drug: SOF/VEL Phase 2

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  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: CDI-31244 + SOF/VEL
CDI-31244 in combination with SOF/VEL
Drug: CDI-31244
investigational drug
Other Name: CDI-31244 (non-nucleoside inhibitor or NNI)

Drug: SOF/VEL
sofosbuvir and velpatasvir fixed dose combination
Other Name: Epclusa




Primary Outcome Measures :
  1. Number of 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

  2. Proportion of participants with sustained virologic response (SVR) 12 weeks [ Time Frame: post-treatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12


Secondary Outcome Measures :
  1. Proportion of participants with sustained virologic response (SVR) 24 weeks after discontinuation of therapy (SVR12) [ Time Frame: post-treatment Week 24 ]
    SVR 24 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 24 weeks after stopping study treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501550


Locations
United States, Maryland
Institute of Human Virology University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Cocrystal Pharma, Inc.
Investigators
Principal Investigator: Joel Chua, MD Institute of Human Virology, University of Maryland, Baltimore

Responsible Party: Cocrystal Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03501550     History of Changes
Other Study ID Numbers: CDI-31244-P2-001
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cocrystal Pharma, Inc.:
HCV
GT1

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents