Respiratory Distress Syndrome in Premature InfantPhase 1/2NCT01473264

Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)

A Phase 1/2 study testing recombinant human CC10 (rhCC10) in people with Respiratory Distress Syndrome in Premature Infant and Bronchopulmonary Dysplasia, run by Clarassance, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 24 to 29 weeks
Conditions the study is for: Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
What is being tested?: recombinant human CC10 (rhCC10)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 4 sitesUnited States
Study dates: Jan 2000to Dec 2003
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 29 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

Newborn infants were considered for the study if the following criteria were met:
Age < 24 hours;
Birthweight between 700 and 1,300 grams;
Gestational age greater than or equal to 24 weeks;
Diagnosis of neonatal RDS based on clinical and radiographic criteria;
Requiring intubation and mechanical ventilation for treatment of RDS;
Received at least one dose of surfactant 100 mg/kg (Survanta; Ross Laboratories);
Written informed consent from the infant's parent or legal guardian prior to enrollment of the patient and agrees to all study-related procedures and evaluations, including those required after hospital discharge.

Who cannot join

Major congenital abnormalities (chromosomal, genetic, cardiac, pulmonary, or renal);

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Maryland School of Medicine
Baltimore, Maryland, 21201
Mercy Medical Center
Baltimore, Maryland, 21202
Winthrop-University Hospital, SUNY Stony Brook School of Medicine
Mineola, New York, 11501
Christiana HealthCare Systems
Wilmington, Delaware, 19899

Other trials in United States

About this study

Official title: Safety and Tolerability of Recombinant Human Clara Cell 10kDa Protein (rhCC10) Delivered Intratracheally 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 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 was 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 respiratory morbidity (CRM; 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 CRM in these infants.

Conditions: Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Being tested: recombinant human CC10 (rhCC10), placebo
Keywords: CC10, BPD, Bronchopulmonary dysplasia, premature infants, neonates, pulmonary inflammation, lung function, RDS
Medical subject headings: Bronchopulmonary Dysplasia, Premature Birth, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

recombinant human CC10 (rhCC10)Drug
Also called rhCC10, CC10, uteroglobin, Clara cell secretory protein
5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.
recombinant human CC10 (rhCC10)Drug
Also called rhCC10, CC10, uteroglobin, Clara cell secretory protein
1.5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg
placeboDrug
Half normal saline solution; single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.

Study groups in NCT01473264
Study group	Role	What they receive
Control	Placebo comparator	Not described Receives: Drug: placebo
High dose rhCC10	Experimental	5 mg/kg study drug (rhCC10) Receives: Drug: recombinant human CC10 (rhCC10)
Low Dose rhCC10	Experimental	1.5 mg/kg study drug (rhCC10) Receives: Drug: recombinant human CC10 (rhCC10)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and type of adverse events
All adverse events were monitored according to the NCI Common Toxicity Criteria. In addition, adverse events specific to, or likely to occur in, premature infants were also monitored, including apnea/bradycardia, sepsis (culture-confirmed), patent ductus arteriosus, retinopathy of prematurity, intraventricular hemorrhage, periventricular leukomalacia, and necrotizing enterocolitis (NEC).
Measured: Adverse events were monitored through 36 wks post-menstrual age (PMA) or hospital discharge

Secondary outcomes (4)

Assessment of pulmonary inflammatory markers
Total cell and neutophil counts were performed on TAF fluids. In addition, a panel of cytokines were measured in TAF from patients at times 0, 1, and 2 days
Measured: Days 0-7
Total number of days on mechanical ventilation
Measured: Through 36 wks postmenstrual age or discharge
Hospitalization at 36 weeks PMA
Measured: Through 36 wks postmenstrual age or discharge
Chronic Respiratory Morbidity
Physical exams and Bayley neurological exams were performed at 12 months PMA. Data pertaining to respiratory outcomes were collected at 6 and 12 months PMA.
Measured: 6 & 12 months postmenstrual age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2000Dec 2003

First posted17 Nov 2011 (estimated)
Study startJan 2000
Primary completionJun 2002
Study completionDec 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Distress Syndrome in Premature InfantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01473264
Sponsor's protocol ID: CC10-2000-001
Other IDs: 9R44HL066965-02
Status last verified: Nov 2011
First submitted: 14 Nov 2011
Last updated: 17 Nov 2011
Results posted: No
Data monitoring committee: Yes

Publications

Levine CR, Gewolb IH, Allen K, Welch RW, Melby JM, Pollack S, Shaffer T, Pilon AL, Davis JM. The safety, pharmacokinetics, and anti-inflammatory effects of intratracheal recombinant human Clara cell protein in premature infants with respiratory distress syndrome. Pediatr Res. 2005 Jul;58(1):15-21. doi: 10.1203/01.PDR.0000156371.89952.35. Epub 2005 Mar 17.
PubMed 15774846

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress

All Respiratory Distress Syndrome in Premature Infant trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Tolerability of Recombinant Human Clara Cell 10kDa Protein (rhCC10) Delivered Intratracheally to Premature Neonates With Respiratory Distress Syndrome
ClinicalTrials.gov ID: NCT01473264
Acronym / sponsor ID: CC10-2000-001
Conditions: Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Keywords: CC10, BPD, Bronchopulmonary dysplasia, premature infants, neonates, pulmonary inflammation, lung function, RDS
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Clarassance, Inc.Industry (pharma, biotech, devices)
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jan 2000
Primary completion: Jun 2002 (actual)
Study completion: Dec 2003 (actual)
First posted: 17 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Control	Placebo comparator	Drug: placebo
High dose rhCC10	Experimental	Drug: recombinant human CC10 (rhCC10)5 mg/kg study drug (rhCC10)
Low Dose rhCC10	Experimental	Drug: recombinant human CC10 (rhCC10)1.5 mg/kg study drug (rhCC10)

Who may qualify

Ages: 24 to 29 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Age < 24 hours;
Birthweight between 700 and 1,300 grams;
Gestational age greater than or equal to 24 weeks;
Diagnosis of neonatal RDS based on clinical and radiographic criteria;
Requiring intubation and mechanical ventilation for treatment of RDS;

Key exclusion criteria (1 listed)

Major congenital abnormalities (chromosomal, genetic, cardiac, pulmonary, or renal);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
recombinant human CC10 (rhCC10)Also: rhCC10, CC10, uteroglobin, Clara cell secretory protein5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.	Drug	High dose rhCC10
recombinant human CC10 (rhCC10)Also: rhCC10, CC10, uteroglobin, Clara cell secretory protein1.5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg	Drug	Low Dose rhCC10
placeboHalf normal saline solution; single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.	Drug	Control

Primary outcome

Number and type of adverse events
Time frame: Adverse events were monitored through 36 wks post-menstrual age (PMA) or hospital discharge
All adverse events were monitored according to the NCI Common Toxicity Criteria. In addition, adverse events specific to, or likely to occur in, premature infants were also monitored, including apnea/bradycardia, sepsis (culture-confirmed), patent ductus arteriosus, retinopathy of prematurity, intraventricular hemorrhage, periventricular leukomalacia, and necrotizing enterocolitis (NEC).

4 secondary outcomes

Assessment of pulmonary inflammatory markers
Time frame: Days 0-7
Total number of days on mechanical ventilation
Time frame: Through 36 wks postmenstrual age or discharge
Hospitalization at 36 weeks PMA
Time frame: Through 36 wks postmenstrual age or discharge
Chronic Respiratory Morbidity
Time frame: 6 & 12 months postmenstrual age

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
Results publication: PubMed 15774846Levine CR, Gewolb IH, Allen K, Welch RW, Melby JM, Pollack S, Shaffer T, Pilon AL, Davis JM. The safety, pharmacokinetics, and anti-inflammatory effects of intratracheal recombinant human Clara cell protein in premature infants with respiratory distress syndrome. Pediatr Res. 2005 Jul;58(1):15-21. doi: 10.1203/01.PDR.0000156371.89952.35. Epub 2005 Mar 17.

Related trials for Respiratory Distress Syndrome in Premature Infant

Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonathan M Davis, MD principal investigator

Dept of pediatrics, Winthrop University Hospital, SUNY Stony Brook School of Medicine

Ira Gewolb, M.D. principal investigator

University of Maryland, Baltimore

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and type of adverse events (time frame: Adverse events were monitored through 36 wks post-menstrual age (PMA) or hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01473264, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2011.