Efficacy of Recombinant Human Clara Cell Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 13 Jun 2017
At a glance
- Drugs Uteroglobin (Primary)
- Indications Asthma; Bronchopulmonary dysplasia; Cough; Respiratory distress syndrome; Respiratory tract infections; Wheezing
- Focus Therapeutic Use
- Acronyms rhCC10 Study 2013
- Sponsors Therabron Therapeutics
- 12 Sep 2016 Planned End Date changed from 1 Jul 2017 to 1 Aug 2017.
- 12 Sep 2016 Planned primary completion date changed from 1 Mar 2017 to 1 Aug 2017.
- 02 Jun 2016 According to a Therabron Therapeutics media release, the company announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to rhCC10, for the prevention of bronchopulmonary dysplasia and chronic respiratory morbidity (CRM) in preterm infants, which supplements the Fast Track Designation recently granted by the FDA for rhCC10 and this trial has been supported, in part, by a grant from the U.S. FDA Office of Orphan Product Development.