Clinical Trial VICCPED1354
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
- 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
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.
|Ages Eligible for Study:||18 Years to 89 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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.
• 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.