AdAPT: Adenovirus after Allogeneic Paediatric Transplantation
Research type
Research Study
Full title
An Open-Label, Randomized, Multi-Center, Parallel Group, Two-Arm Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir versus Standard of Care for Treatment of Adenovirus Infections in High-Risk Pediatric Allogeneic Hematopoietic Cell Transplant Recipients.
IRAS ID
229785
Contact name
Robert Francis Wynn
Contact email
Sponsor organisation
Chimerix Inc
Eudract number
2017-001735-39
Clinicaltrials.gov Identifier
110,584, US IND No
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Adenoviruses (AdV) belong to a group of viruses called double-stranded DNA viruses (dsDNA). In people with healthy immune systems, an AdV infection is usually no worse than catching the common cold. In patients without a healthy immune system, AdV infections can lead to serious disease. This includes bone marrow transplant patients waiting for the new graft to fully establish itself and restore their immune function.
No drugs have been approved for the treatment of AdV. One drug used with limited success is called cidofovir. Cidofovir is indicated for the treatment of cytomegalovirus (CMV) retinitis, in adults with AIDS and without renal dysfunction. Cidofovir can only be given by intravenous (into the vein) injection and can sometimes cause damage to the kidneys.
Brincidofovir (BCV) is a modified form of cidofovir. BCV (previously known as CMX001) is being developed by the study sponsor, Chimerix. BCV is taken by mouth and is converted into cidofovir inside the body. As a modified form of cidofovir BCV is less toxic to kidneys. BCV has not been approved by the MHRA or agencies in other countries.
The main aim of this study is to determine whether BCV is a safe and effective treatment for AdV by comparing BCV against standard of care treatments at various study sites. This may include cidofovir, if available, as well as making changes to the subjects’ immunosuppressive drugs. The study doctor may also “wait-and-see” to see if the infection can be controlled by the subjects’ immune system alone.
The study will be conducted at hospitals in North America and Europe, and will enrol about 140 children aged up to 17 years old with AdV infection.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0474
Date of REC Opinion
5 Jan 2018
REC opinion
Further Information Favourable Opinion