Brincidofovir (CMX001) for Treatment of Ebola Virus Disease
Research type
Research Study
Full title
An Open-Label, Multicenter Study of the Safety,Tolerability and Antiviral Activity of Brincidofovir(CMX001) for Treatment of Ebola Virus Disease
IRAS ID
167330
Contact name
Michael Jacobs
Contact email
Sponsor organisation
Chimerix UK Ltd
Eudract number
2014-004458-33
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
124,072, US IND No:
Duration of Study in the UK
1 years, 2 months, 17 days
Research summary
The Ebola virus (EBOV) causes an acute, serious illness, characterized by high fever, severe gastrointestinal (GI) symptoms, especially diarrhea, widespread organ involvement and, at times, severe hemorrhagia, which is often rapidly fatal if untreated.
The first cases in the current outbreak were reported in March 2014 and it has since become the largest outbreak since the original outbreaks were reported in 1976. It has spread between countries originally starting in Guinea then spreading to Sierra Leone, Liberia, Nigeria, and Senegal.
Brincidofovir (CMX001; BCV) is an orally-available lipid conjugate of the nucleotide analog, cidofovir (CDV), and provides for intracellular delivery of the active antiviral cidofovir-diphosphate. In vitro and in vivo data support a broad-spectrum of activity against double-stranded deoxyribonucleic acid (dsDNA) viruses, including herpesviruses, adenoviruses (AdV), and poxviruses.
BCV is administered orally as twice-weekly (BIW) doses of 100 mg in subjects weighing = 50 kg, and at weight-based doses of 2 mg/kg in subjects weighing < 50 kg. BCV has been provided to more than 400 patients with serious or life-threatening infections with dsDNA viral infections and no alternative treatment options under expanded access or emergency investigational new drug (EIND) or local equivalent regulations in nine countries, including the USA, Canada, France, United Kingdom, Spain, Switzerland, Austria, Israel, and Peru.
This is a single-arm, open-label study of BCV to treat EBOV-infected patients evacuated outside of Africa for care, as well as any new infections that occur outside of the epidemic regions for the current outbreak, as a proof-of-concept study for determining whether there is a potential role for BCV therapy in the ongoing EVD outbreak.REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1379
Date of REC Opinion
11 Dec 2014
REC opinion
Further Information Favourable Opinion