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Eksperiment

Evaluation of the Efficacy and Safety of ABC-5678 in Adults with Chronic Epstein-Barr Virus (EBV) Infection

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABC-5678 in Adults with Chronic Epstein-Barr Virus (EBV) Infection

Trial Locations

Multiple centers across the United States

Background

Epstein-Barr virus (EBV) is a common herpesvirus that can lead to chronic infection in some individuals, resulting in long-term fatigue, muscle pain, and cognitive impairments. There is currently no specific treatment for chronic EBV infection, and this trial aims to evaluate the efficacy and safety of ABC-5678, an investigational antiviral drug that targets EBV replication.

Objectives

  1. Primary Objective: To assess the efficacy of ABC-5678 in reducing the severity and duration of fatigue in adults with chronic EBV infection.

  2. Secondary Objectives:

    • To evaluate the impact of ABC-5678 on muscle pain and cognitive function.

    • To assess the improvement in overall quality of life.

    • To evaluate the safety and tolerability of ABC-5678.

Study Design

  • Type: Randomized, double-blind, placebo-controlled

  • Estimated Enrollment: 300 participants

  • Allocation: 1:1 ratio to either ABC-5678 or placebo

  • Intervention Model: Parallel assignment

  • Masking: Double (participant and investigator)

  • Primary Purpose: Treatment

Inclusion Criteria

  • Adults aged 18-65 years

  • Confirmed chronic EBV infection (positive EBV DNA and symptoms lasting more than six months)

  • Persistent symptoms of fatigue and muscle pain

  • Ability to understand and sign the informed consent form

Exclusion Criteria

  • Current participation in another clinical trial

  • Known hypersensitivity to ABC-5678 or its components

  • Significant underlying health conditions that may interfere with study outcomes (e.g., severe heart disease, uncontrolled diabetes)

  • Pregnant or breastfeeding women

Interventions

  • Experimental Group: ABC-5678, oral administration, dosage as per protocol

  • Control Group: Placebo, oral administration, matched in appearance to ABC-5678

Outcome Measures

  • Primary Outcome Measure: Change in fatigue severity from baseline to 12 weeks, measured by the Fatigue Severity Scale (FSS).

  • Secondary Outcome Measures

    • Change in muscle pain from baseline to 12 weeks, assessed by the Visual Analog Scale for Pain (VAS Pain).

    • Change in cognitive function from baseline to 12 weeks, assessed by the Cognitive Failures Questionnaire (CFQ).

    • Improvement in overall quality of life from baseline to 12 weeks, evaluated using the SF-36 Health Survey.

    • Incidence of adverse events throughout the study duration.

Study Timeline

  • Estimated Start Date: September 1, 2024

  • Estimated Primary Completion Date: February 28, 2026

  • Estimated Study Completion Date: August 31, 2026

Safety Monitoring

An independent Data Safety Monitoring Board (DSMB) will oversee the trial's safety data and recommend continuation, modification, or termination of the study based on predefined criteria.

Statistical Analysis

  • Primary Efficacy Analysis: Comparison of the change in fatigue severity between the ABC-5678 and placebo groups using mixed-effects models for repeated measures (MMRM).

  • Secondary Analyses: Similar models for muscle pain, cognitive function, and quality of life, along with descriptive statistics for safety outcomes.

Contact Information

For more information, potential participants or referring physicians can contact the study coordinator at Connected Research & Consulting:

Conclusion

This clinical trial aims to address the unmet need for effective treatments for chronic EBV infection by evaluating the potential benefits and safety of ABC-5678. The results of this study could provide significant insights into the management of chronic EBV and improve the quality of life for affected individuals.

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