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Completed

NCT Number: NCT03501550

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

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

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Human Virology University of Maryland

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDI-31244

Drug

investigational drug

Other names: CDI-31244 (non-nucleoside inhibitor or NNI)

SOF/VEL

Drug

sofosbuvir and velpatasvir fixed dose combination

Other names: Epclusa

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cocrystal Pharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2018
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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