Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Sponsor: |
AlloVir, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU0859 |
U.S. Govt. ID: |
NCT04693637 |
Contact: |
Dylan Stein: 212-305-3268 / djs2245@cumc.columbia.edu |
Are you undergoing a stem cell transplant? You may be at high risk for infections after the transplant. This study is looking at the safety and effectiveness of an investigational medication for those who have undergone a stem cell transplant. Recovery after a stem cell transplant can already be challenging without the added worry of life-threatening viral reinfections. It may be worth exploring the possibilities and peace of mind a clinical trial can offer. This is a Phase 2/3 study to evaluate the efficacy and safety of ALVR105 (also known as Viralym-M and formerly known as ALVR-105) for the prevention of clinically significant adenovirus (AdV), BK virus(BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus 6 (HHV-6), and JohnCunningham virus (JCV) infections and/or disease in patients at high risk for these viruses following allogeneic hematopoietic cell transplant (HCT). Patients that qualify and choose to enroll in the study may be reimbursed for study-related travel expenses. Participation for this study is divided into three periods: 1. Screening: up to 10 weeks, 2. Treatment: 14 weeks, 3. Follow-up: 12 weeks
This study is closed
Investigator
Prakash Satwani, MD
Are you or your child at least one year old? |
Yes |
No |
Have you or your child recently undergone or preparing to undergo a stem cell transplant? |
Yes |
No |