A Randomized, Placebo-Controlled Multi-Site Phase 2 Study Evaluation the Safety and Efficacy of Preemptive Treatment With CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation in Adults and Children
The primary objective of this study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT with asymptomatic AdV viremia.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : CMX001
Phase: Phase 2
Ages Eligible For Study:
1. Males and females ? 3 months and ? 75 years of age. 2. Subjects have received an allogeneic HSCT. 3. Positive serum AdV PCR (> 100 copies/mL) as measured by the central laboratory. 4. Subject or guardian(s) are willing to comply with the protocol. 5. Subject or guardian(s) are willing and able to understand the informed consent/assent. 6. Females of child-bearing potential must have a negative pregnancy test (serum beta-hCG) and sexually active females must use a reliable and medically approved method of contraception throughout the study. Sexually active males of procreation potential must be able and willing to use a reliable and medically approved contraceptive method throughout the study. At least one barrier method of contraception must be used, in subjects of procreation potential.