Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01941745 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Bronchopulmonary Dysplasia and Respiratory Distress Syndrome in Premature Infant, sponsored by Tufts Medical Center.

Completed
Registry status
Phase 2
Development phase
88
Enrollment target
3
Study locations

NCT01941745 is a Phase 2 study of Bronchopulmonary Dysplasia and Respiratory Distress Syndrome in Premature Infant that has completed, run by Tufts Medical Center. The registered enrollment target is 88 participants, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (62% lower). The trial reports 3 study locations across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01941745, a Phase 2 study of Bronchopulmonary Dysplasia and Respiratory Distress Syndrome in Premature Infant, has completed, sponsored by Tufts Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
88 participants
Enrollment target
3
Study locations

Study 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 Studied

Bronchopulmonary Dysplasia Respiratory Distress Syndrome in Premature Infant

Interventions

  • DRUG Half normal saline
  • DRUG Low Dose rhCC10
  • DRUG High dose rhCC10

Study Locations (3)

Massachusetts

  • Tufts Medical Center - Boston
  • Brigham and Women's Hospital - Boston
  • Baystate Medical Center - Springfield

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2013-10
Est. Completion 2017-08-25
Phase Phase 2

Sponsor

Tufts Medical Center

169 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01941745

The ClinicalTrials.gov registry entry for NCT01941745 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (62% lower). The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 3 interventions - of which Half normal saline is the first listed.

NCT01941745 reports 3 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01941745 about?

NCT01941745 is a clinical study titled "Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome". 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 c...

What is the current status of trial NCT01941745?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2013-10. Estimated completion is 2017-08-25.

What conditions does trial NCT01941745 study?

This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant.

What interventions are being tested in trial NCT01941745?

The interventions under investigation include: Half normal saline (DRUG), Low Dose rhCC10 (DRUG), High dose rhCC10 (DRUG).

Who is sponsoring clinical trial NCT01941745?

This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01941745 being conducted?

This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Bronchopulmonary Dysplasia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Bronchopulmonary Dysplasia

All registered trials for this condition

Respiratory Distress Syndrome in Premature Infant

All registered trials for this condition

Massachusetts

All trials with a study site in Massachusetts

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.