Trial Outcomes & Findings for A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus (NCT NCT02439957)
NCT ID: NCT02439957
Last Updated: 2021-07-16
Results Overview
The incidence of CMV disease, which included CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and Week 24 posttransplant (±14 days). The proportion of subjects who 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). Number of failures and failure rates were to be presented for each treatment. 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.
TERMINATED
PHASE3
6 participants
24 weeks (±14 days)
2021-07-16
Participant Flow
Participant milestones
| Measure |
Treatment 1
100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placeo (2 tablets) once daily.
|
Treatment 2
900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
Blinded Treatment Period
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Treatment 1
100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placeo (2 tablets) once daily.
|
Treatment 2
900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
|
|---|---|---|
|
Overall Study
Study Terminated
|
3
|
3
|
Baseline Characteristics
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
Baseline characteristics by cohort
| Measure |
Treatment 1
n=3 Participants
100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily.
|
Treatment 2
n=3 Participants
900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
n=99 Participants
|
53.7 years
n=107 Participants
|
50.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeks (±14 days)Population: The study was terminated. Enrollment was suspended and all blinded study treatment was discontinued in early January 2016.
The incidence of CMV disease, which included CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and Week 24 posttransplant (±14 days). The proportion of subjects who 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). Number of failures and failure rates were to be presented for each treatment. 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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment 1
Treatment 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment 1
n=3 participants at risk
100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily.
|
Treatment 2
n=3 participants at risk
900 mg valganciclovir (vGCV; two 450 mg tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal discomfort
|
66.7%
2/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3
|
0.00%
0/3
|
|
Vascular disorders
Hot flush
|
33.3%
1/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea intermittent
|
33.3%
1/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
33.3%
1/3
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
33.3%
1/3
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3
|
33.3%
1/3
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/3
|
33.3%
1/3
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
33.3%
1/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3
|
33.3%
1/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within 18 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 60 days to allow Sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER