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Clinical Trial VICCPED1354

Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients

Principal Investigator(s)

Jennifer Domm

Details

  • Protocol No. VICCPED1354
  • Open Date: 03/17/2014
  • Staging: Phase III
  • Age Group: Both Child and Adult
  • Scope: National
  • Objective: The primary objectives of this study are: - To compare the efficacy of CMX001 to placebo for the prevention of clinically significant CMV infection in R+ allogeneic hematopoietic stem cell transplant (HSCT) recipients - To compare the safety and tolerability of CMX001 to placebo
  • Disease Sites: Pediatrics; Hematologic
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: CMX001
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01769170
  • Secondary Protocol No: CMX001-301

Description

The main purpose of this study is to find out whether an investigational drug called CMX001 can be used to prevent CMV infection after hematopoietic cell transplant.

Eligibility

Ages Eligible for Study:18 Years to 89 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Subjects will be adult allogeneic HSCT recipients aged ≥ 18 years-old (or as applicable, per local law) who were CMV seropositive before transplantation and are CMV viremia negative posttransplant.
Exclusion Criteria:
• Subjects who have a positive CMV viremia test at any time between transplant and the First Dose Day (FDD).
• Subjects with hypersensitivity (not renal dysfunction or eye disorder) to CDV or to CMX001 or its excipients.
• Subjects who have received any anti-CMV therapy and investigational anti-CMV drugs at any time posttransplant.
• Subjects who have had any anti-CMV vaccine at any time.