Persistent Pulmonary Hypertension of the Newborn

Summary

The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.

Timeline

Start

2011-12

Primary completion

2013-12

Completion

2014-01

Outcome

Missed primary endpoint

Stopped: “To be compliant with the timelines as agreed with Paediatric Committee (PC) within the Paediatric Investigational Plan”

registry analysis (unspecified test); Bosentan vs Placebo; p = 1; Fisher Exact NCT01389856 ↗

registry analysis (unspecified test); Bosentan vs Placebo; p = 0.3407; Log Rank NCT01389856 ↗

registry analysis (unspecified test); Bosentan vs Placebo; p = 0.2399; Log Rank NCT01389856 ↗

Publications

• Steinhorn RH, Fineman J, Kusic-Pajic A, Cornelisse P, Gehin M, Nowbakht P, Pierce CM, Beghetti M; FUTURE-4 study investigators. Bosentan as Adjunctive Therapy for Persistent Pulmonary Hypertension of the Newborn: Results of the Randomized Multicenter Placebo-Controlled Exploratory Trial. J Pediatr. 2016 Oct;177:90-96.e3. doi: 10.1016/j.jpeds.2016.06.078. Epub 2016 Aug 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bosentan	Other / unclassified	2 mg/kg	Other

Indications