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

NCT ID: NCT03501550

Last Updated: 2021-04-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2019-06-07

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CDI-31244 + SOF/VEL

CDI-31244 in combination with SOF/VEL

Group Type EXPERIMENTAL

CDI-31244

Intervention Type DRUG

investigational drug

SOF/VEL

Intervention Type DRUG

sofosbuvir and velpatasvir fixed dose combination

Interventions

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CDI-31244

investigational drug

Intervention Type DRUG

SOF/VEL

sofosbuvir and velpatasvir fixed dose combination

Intervention Type DRUG

Other Intervention Names

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CDI-31244 (non-nucleoside inhibitor or NNI) Epclusa

Eligibility Criteria

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Inclusion Criteria

Documented chronic HCV GT 1 infection; Serum HCV RNA \>1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cocrystal Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel Chua, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Human Virology, University of Maryland, Baltimore

Locations

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Institute of Human Virology University of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CDI-31244-P2-001

Identifier Type: -

Identifier Source: org_study_id

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