Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome

Summary

Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection. These conditions initiate an inflammatory response characterized by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the development of significant acute and chronic lung injury.

The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10 is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is the most abundant protein in the mucosal fluids in normal healthy lungs.

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated premature infants receiving positive pressure ventilation for treatment of respiratory distress syndrome (RDS) to prevent long term respiratory complications referred to as bronchopulmonary dysplasia, and, more recently, as Chronic Pulmonary Insufficiency of Prematurity (CPIP; asthma, cough, wheezing, multiple respiratory infections).

CC10 regulates inflammatory responses and protects the structural integrity of pulmonary tissue while preserving pulmonary mechanical function during various insults (eg. viral infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties suggest that administration of rhCC10 may help to facilitate development of normal airway epithelia and prevent the inflammation that leads to CPIP in these infants.

This study is funded by the FDA Office of Orphan Product Development (OOPD).

Conditions

• Respiratory Distress Syndrome in Premature Infant
• Bronchopulmonary Dysplasia

Interventions

DRUG

Half normal saline

2 ml/kg

DRUG

Low Dose rhCC10

1.5 mg/kg study drug (rhCC10)

DRUG

High dose rhCC10

5 mg/kg in 2 ml/kg

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Therabron Therapeutics, Inc.

  collaborator INDUSTRY

• Baystate Medical Center

  collaborator OTHER

• Poznan University of Medical Sciences

  collaborator OTHER

• SP ZOZ Szpital Uniwersytecki w Krakowie Oddizat Neonatologii

  collaborator UNKNOWN

• Instytut Centrum Zdrowia Matki Polki Klinika Neonatologii

  collaborator UNKNOWN

• Tufts Medical Center

  lead OTHER

Principal Investigators

• Jonathan Davis, MD · Tufts Medical Center

• Richard Parad, MD/MPH · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

24 Weeks

Max Age

29 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2017-08-25

Completion

2017-08-25

Countries

• United States

Study Locations