A Safety and Dose-Determining Study of CMX001 In Infants With Neonatal Herpes Simplex Virus (HSV) Infection Involving the Central Nervous System (CNS Disease)

Phase 1/2 Withdrawn University of Alabama at Birmingham

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is to identify if a Novel Antiviral Drug could be used to treat babies with Herpes Simplex Virus (HSV) with central nervous system (CNS) disease. In this study the investigators will identify the best dose for young children as well as identify additional safety information about the Novel Antiviral Drug.

Timeline

Start: 2016-01
Primary completion: 2017-06
Completion: 2017-06

Outcome

Outcome not reported

Stopped: “Study terminated because unable to obtain access to study drug for study population.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Brincidofovir	Other / unclassified	0.25 mg/kg	Oral
Comparator	Brincidofovir	Other / unclassified	0.5 mg/kg	Oral
Comparator	Brincidofovir	Other / unclassified	1 mg/kg	Oral
Comparator	Brincidofovir	Other / unclassified	2 mg/kg	Oral

A Safety and Dose-Determining Study of CMX001 In Infants With Neonatal Herpes Simplex Virus (HSV) Infection Involving the Central Nervous System (CNS Disease)

Summary

Timeline

Outcome

Drugs

Indications