The Chimerix CMX001 Registry
Research type
Research Study
Full title
A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001
IRAS ID
254219
Contact name
Jesus De La Fuente Pereda
Contact email
Sponsor organisation
Chimerix Inc
Clinicaltrials.gov Identifier
CMXCM333-CMX333, PRA project code
Duration of Study in the UK
11 years, 0 months, 1 days
Research summary
The Chimerix CMX001 Registry is a prospective observational study aiming to establish a registry database to evaluate the potential impact of prior treatment with brincidofovir (BCV, formerly CMX001 that has demonstrated broad antiviral activity) on the long-term incidence of specific events, such as the development of new malignancies, pregnancy outcomes, late cytomegalovirus (CMV)-associated events, graft outcomes, and survival rates in subjects previously enrolled in selected clinical studies of CMX001.\n\nFormer BCV clinical study participants (adults and children) who agree to participate in this Registry will be followed in this observational study for a period of approximately 10 years from each individual’s completion of the qualifying clinical study. During the 10-year follow-up period, subjects will be contacted at periodic intervals (approximately every 6 months for the first 3 years and approximately every 12 months thereafter) to enquire about and document new malignancies, pregnancy outcomes, graft outcomes, and the occurrence of any events associated with late CMV reactivation, as well as the continued survival of the subject. Subjects will not be treated with BCV while participating in the Registry.\n\nThe number of subjects enrolled in the Registry will be determined by the number of subjects who complete participation in qualifying clinical studies and agreeing to participate in the Registry.\n\nThis includes subjects who were not randomized to BCV, but who received placebo or, where applicable, any active comparator drug, who will collectively constitute a control group for the BCV-treated subjects in the Registry. Subjects will remain blinded to their original treatment assignment in qualifying clinical studies, as applicable, until formal unblinding at the end of the respective qualifying study. \n\nThe study will be conducted at multiple study centers in the USA, Canada, and Europe.\n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0082
Date of REC Opinion
8 Apr 2019
REC opinion
Unfavourable Opinion