Trial Outcomes & Findings for A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease (NCT NCT02439970)

Last Updated: 2021-07-16

Results Overview

The incidence of CMV disease included CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and Week 52 (± 28 days). The proportion of subjects that met this failure endpoint were to be compared between brincidofovir (BCV) and valganciclovir (vGCV) using an unadjusted 95% confidence interval (CI) of the absolute difference between groups (BCV minus vGCV). If the upper bound of the 95% CI fell below 10%, BCV would have demonstrated non-inferiority to vGCV. In the event that the upper bound of the 95% CI fell below 0%, BCV would have additionally demonstrated superiority over vGCV.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

5 participants

Primary outcome timeframe

52 weeks (± 28 days)

Results posted on

2021-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment 1 100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.	Treatment 2 900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
Overall Study STARTED	2	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment 1 100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.	Treatment 2 900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
Overall Study Study Terminated	2	3

Baseline Characteristics

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment 1 n=2 Participants BCV plus vGCV placebo Brincidofovir	Treatment 2 n=3 Participants vGCV plus BCV placebo Valganciclovir	Total n=5 Participants Total of all reporting groups
Age, Continuous	37 years n=5 Participants	44.3 years n=7 Participants	41 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks (± 28 days)

Population: The study was terminated. Enrollment was suspended and all blinded study treatment was discontinued in early January 2016. Due to the premature termination of this study, statistical analyses were not performed. Limited demographic and safety data were provided for the 5 subjects enrolled.

Outcome measures

Outcome data not reported

Adverse Events

Treatment 1

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment 2

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment 1 n=2 participants at risk 100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.	Treatment 2 n=3 participants at risk 900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
Gastrointestinal disorders Gastroenteritis	50.0% 1/2	0.00% 0/3
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/2	33.3% 1/3
Renal and urinary disorders Perinephric collection	0.00% 0/2	33.3% 1/3

Other adverse events

Other adverse events
Measure	Treatment 1 n=2 participants at risk 100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.	Treatment 2 n=3 participants at risk 900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2	33.3% 1/3
Nervous system disorders Headache	0.00% 0/2	33.3% 1/3
General disorders Pyrexia	0.00% 0/2	33.3% 1/3
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2	33.3% 1/3
Renal and urinary disorders Hydronephrosis	0.00% 0/2	33.3% 1/3
Gastrointestinal disorders Flatulence	50.0% 1/2	33.3% 1/3
Musculoskeletal and connective tissue disorders Muscle spasms	50.0% 1/2	0.00% 0/3
Gastrointestinal disorders Nausea	100.0% 2/2	33.3% 1/3
Gastrointestinal disorders Vomiting	50.0% 1/2	0.00% 0/3
Renal and urinary disorders Haematuria	50.0% 1/2	0.00% 0/3
Gastrointestinal disorders Diarrhoea	50.0% 1/2	0.00% 0/3
Infections and infestations Urinary tract infection	50.0% 1/2	0.00% 0/3
Metabolism and nutrition disorders Hypokalaemia	50.0% 1/2	0.00% 0/3
Metabolism and nutrition disorders Hypomagnesaemia	50.0% 1/2	33.3% 1/3
Infections and infestations Pseudomonas infection	0.00% 0/2	33.3% 1/3

Additional Information

Chief Medical Officer

Chimerix, Inc.

Phone: 919-806-1074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Within 12 months after the end of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given opportunity to review and comment. Institution publications may be delayed up to an additional 90 days to allow Sponsor to seek patent protection.
Publication restrictions are in place

Restriction type: OTHER