Respiratory Distress Syndrome, NewbornPhase 2NCT02452476

A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)

A Phase 2 study testing CHF5633 and Poractant alfa in people with Respiratory Distress Syndrome, Newborn, run by Chiesi Farmaceutici S.p.A. at 23 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 1 hour to 24 hours
Conditions the study is for: Respiratory Distress Syndrome, Newborn
What is being tested?: CHF5633 and Poractant alfa
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 23 sitesUnited States
Study dates: 21 Jan 2016to 24 May 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 hour to 24 hours
All sexes
No healthy volunteers
Child

Who may be able to join

Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
Inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks
Clinical course consistent with RDS
Requirement of endotracheal surfactant administration within 24 hours from birth
Fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%

Who cannot join

Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
Mothers with prolonged rupture of the membranes (>21 days duration)
Strong suspicion of congenital pneumonia/infection, sepsis
Presence of air leaks prior to study entry

Show all 10Show fewer

Evidence of severe birth asphyxia
Neonatal seizures prior to study entry
Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Jatinder Bhatia
Augusta, Georgia
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio
Case Western Reserve University
Cleveland, Ohio
Texas Tech University Health Sciences Center
El Paso, Texas
Martha Naylor
Greenville, North Carolina
Connecticut Children's Medical Center
Hartford, Connecticut
Indiana University School of Medicine
Indianapolis, Indiana
LAC + USC Medical Center, Keck School of Medicine
Los Angeles, California
University of Louisville Research Foundation, Inc.
Louisville, Kentucky
Winthrop University Hospital
Mineola, New York
University of South Alabama - USA Children's and Women's Hospital
Mobile, Alabama
West Virginia University
Morgantown, West Virginia
Kings County Hospital Center
New York, New York
Krishnamurthy Sekar
Oklahoma City, Oklahoma
UC Irvine Medical Center
Orange, California
Hahnemann University Hospital
Philadelphia, Pennsylvania
Plantation General Hospital (Sheridan Clinical Research, Inc.)
Plantation, Florida
Sharp Mary Birch Hospital
San Diego, California
Memorial Hospital of South Bend
South Bend, Indiana
Baystate Children's Hospital / Baystate Medical Center
Springfield, Massachusetts
MultiCare Institute for Research & Innovation
Tacoma, Washington
Sergio G. Golombek
Valhalla, New York

Other trials in United States

About this study

Official title: A DOUBLE BLIND, RANDOMIZED, CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF SYNTHETIC SURFACTANT (CHF 5633) IN COMPARISON TO PORCINE SURFACTANT (PORACTANT ALFA, CUROSURF®) IN THE TREATMENT OF PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME

A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. Main objectives of this study are to investigate the short term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of prematurity.

Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with RDS, requirement of endotracheal surfactant administration within 24 hours from birth, fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain arterial oxygen saturation by pulse oximetry (SpO2) between 88-95%.

Conditions: Respiratory Distress Syndrome, Newborn
Being tested: CHF5633, Poractant alfa
Keywords: neonates, pulmonary surfactant
Medical subject headings: Respiratory Distress Syndrome, Newborn

What participants receive

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

CHF5633Drug
Rescue treatment (if needed)
Poractant alfaDrug
Rescue treatment (if needed)

Study groups in NCT02452476
Study group	Role	What they receive
CHF5633	Experimental	Single dose within 24 hours from birth Receives: Drug: CHF5633
Poractant alfa	Active comparator	Single dose within 24 hours from birth Receives: Drug: Poractant alfa

What is being measured

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

Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
SpO2/FiO2 ratio
The oxygen requirement and ventilatory support were assessed through arterial oxygen saturation, measured by pulse oximetry (SpO2 [%]) and ventilator settings, by measuring fraction of inspired oxygen (FiO2[%]) and SpO2/FiO2. Results are shown as change from baseline, summarized at post-treatment timepoints.
Definitions:
SpO2=Arterial Oxygen saturation by pulse oximetry; FiO2=Fraction of inspired oxygen; Baseline=The last pre-dose measurement taken on Day -1.
Measured: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Fraction of inspired oxygen (FiO2) (percent) during the first 24 h and up to Day 7.
Fraction of inspired oxygen (FiO2 [percent]). Results are shown as change from baseline, summarized at post-treatment time points.
Definitions:
FiO2=Fraction of inspired oxygen (percent); Baseline=The last pre-dose measurement taken on Day -1;
Measured: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7
Number of Patients With Bronchopulmonary Dysplasia and Mortality
Bronchopulmonary dysplasia and mortality.
Results summarize the following items:
Number of patients who died and the number of patients who had bronchopulmonary dysplasia (BPD) were assessed by treatment, at 36 weeks post menstrual age (PMA).
Number of patients who died by Day 28 post-natal age (PNA).
Number of patients with respiratory distress syndrome (RDS)-associated mortality by Day 14 post-natal age (PNA).
Definitions:
BPD=Bronchopulmonary dysplasia; Mortality/BPD incidence=The incidence of neonates dead within 36-week PMA or alive at 36-week PMA with a diagnosis of BPD; PMA=Post menstrual age; PNA=Post-natal age; RDS=Respiratory distress syndrome;
Measured: 36 weeks post menstrual age, Day 14 Post-Natal Age, Day 28 Post-Natal Age

Timeline

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

21 Jan 201624 May 2018

First posted22 May 2015 (estimated)
Study start21 Jan 2016
Primary completion24 May 2018
Study completion24 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02452476
Sponsor's protocol ID: CCD-05633AA1-02
Status last verified: Jul 2021
First submitted: 20 May 2015
Last updated: 13 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ramanathan R, Biniwale M, Sekar K, Hanna N, Golombek S, Bhatia J, Naylor M, Fabbri L, Varoli G, Santoro D, Del Buono D, Piccinno A, Dammann CE. Synthetic Surfactant CHF5633 Compared with Poractant Alfa in the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter, Double-Blind, Randomized, Controlled Clinical Trial. J Pediatr. 2020 Oct;225:90-96.e1. doi: 10.1016/j.jpeds.2020.06.024. Epub 2020 Jun 14.
PubMed 32553868

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

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All Respiratory Distress Syndrome, Newborn trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A DOUBLE BLIND, RANDOMIZED, CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF SYNTHETIC SURFACTANT (CHF 5633) IN COMPARISON TO PORCINE SURFACTANT (PORACTANT ALFA, CUROSURF®) IN THE TREATMENT OF PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME
ClinicalTrials.gov ID: NCT02452476
Acronym / sponsor ID: CCD-05633AA1-02
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: neonates, pulmonary surfactant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
Study start: 21 Jan 2016 (actual)
Primary completion: 24 May 2018 (actual)
Study completion: 24 May 2018 (actual)
First posted: 22 May 2015 (estimated)
Results: Posted 23 Jun 2021

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CHF5633	Experimental	Drug: CHF5633Single dose within 24 hours from birth
Poractant alfa	Active comparator	Drug: Poractant alfaSingle dose within 24 hours from birth

Who may qualify

Ages: 1 hour to 24 hours
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
Inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks
Clinical course consistent with RDS
Requirement of endotracheal surfactant administration within 24 hours from birth
Fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%

Key exclusion criteria (10 listed)

Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
Mothers with prolonged rupture of the membranes (>21 days duration)
Strong suspicion of congenital pneumonia/infection, sepsis

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
CHF5633Rescue treatment (if needed)	Drug	CHF5633
Poractant alfaRescue treatment (if needed)	Drug	Poractant alfa

Primary outcome

Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Time frame: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7
SpO2/FiO2 ratio The oxygen requirement and ventilatory support were assessed through arterial oxygen saturation, measured by pulse oximetry (SpO2 [%]) and ventilator settings, by measuring fraction of inspired oxygen (FiO2[%]) and SpO2/FiO2. Results are shown as change from baseline, summarized at post-treatment timepoints. Definitions: SpO2=Arterial Oxygen saturation by pulse oximetry; FiO2=Fraction of inspired oxygen; Baseline=The last pre-dose measurement taken on Day -1.
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Time frame: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7
Fraction of inspired oxygen (FiO2) (percent) during the first 24 h and up to Day 7. Fraction of inspired oxygen (FiO2 [percent]). Results are shown as change from baseline, summarized at post-treatment time points. Definitions: FiO2=Fraction of inspired oxygen (percent); Baseline=The last pre-dose measurement taken on Day -1;
Number of Patients With Bronchopulmonary Dysplasia and Mortality
Time frame: 36 weeks post menstrual age, Day 14 Post-Natal Age, Day 28 Post-Natal Age
Bronchopulmonary dysplasia and mortality. Results summarize the following items: Number of patients who died and the number of patients who had bronchopulmonary dysplasia (BPD) were assessed by treatment, at 36 weeks post menstrual age (PMA). Number of patients who died by Day 28 post-natal age (PNA). Number of patients with respiratory distress syndrome (RDS)-associated mortality by Day 14 post-natal age (PNA). Definitions: BPD=Bronchopulmonary dysplasia; Mortality/BPD incidence=The incidence of neonates dead within 36-week PMA or alive at 36-week PMA with a diagnosis of BPD; PMA=Post menstrual age; PNA=Post-natal age; RDS=Respiratory distress syndrome;

Results and safety

Results posted to the registry on 23 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHF5633	64	53
Poractant Alfa	59	49

Primary outcome: Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio

Time frame: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7. Least squares mean (95% Confidence Interval). Unit: SpO2/FiO2 ratio

Measure	CHF5633 n = 56	Poractant Alfa n = 57
Day 1, 30 min	3.33 (3.02 to 3.63)	3.31 (3.00 to 3.61)
Day 1, 1 h	3.36 (3.07 to 3.66)	3.55 (3.26 to 3.84)
Day 1, 3 h	3.58 (3.33 to 3.83)	3.68 (3.44 to 3.93)
Day 1, 6 h	3.77 (3.52 to 4.02)	3.87 (3.63 to 4.12)
Day 1, 12 h	3.89 (3.65 to 4.13)	3.78 (3.54 to 4.01)
Day 1, 18 h	3.82 (3.59 to 4.04)	3.74 (3.52 to 3.97)
Day 1, 24 h	3.72 (3.47 to 3.98)	3.64 (3.38 to 3.89)
Day 2	3.61 (3.35 to 3.86)	3.63 (3.38 to 3.88)

CHF5633 vs Poractant Alfa: Mean Difference (Final Values): 0.02 (95% CI -0.40 to 0.44), p = 0.930, Mixed model for repeated measurements
CHF5633 vs Poractant Alfa: Mean Difference (Final Values): -0.19 (95% CI -0.59 to 0.21), p = 0.346, Mixed model for repeated measurements
CHF5633 vs Poractant Alfa: Mean Difference (Final Values): -0.10 (95% CI -0.43 to 0.23), p = 0.549, Mixed model for repeated measurements

Population analysed: Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.

Primary outcome: Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7

Time frame: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7. Least squares mean (95% Confidence Interval). Unit: Fraction of inspired oxygen (percent)

Measure	CHF5633 n = 56	Poractant Alfa n = 57
Day 1, 30 min	32.15 (27.91 to 36.39)	34.08 (29.88 to 38.29)
Day 1, 1 h	31.41 (28.14 to 34.68)	28.96 (25.76 to 32.16)
Day 1, 3 h	29.29 (26.05 to 32.52)	28.87 (25.68 to 32.06)
Day 1, 6 h	27.76 (24.43 to 31.08)	28.16 (24.88 to 31.45)
Day 1, 12 h	25.28 (22.71 to 27.85)	28.05 (25.53 to 30.58)
Day 1, 18 h	26.18 (24.02 to 28.34)	28.10 (25.97 to 30.23)
Day 1, 24 h	28.49 (25.02 to 31.96)	29.50 (26.05 to 32.95)
Day 2	29.29 (26.52 to 32.06)	29.20 (26.46 to 31.93)

CHF5633 vs Poractant Alfa: Mean Difference (Final Values): -1.94 (95% CI -7.87 to 3.99), p = 0.519, Mixed model for repeated measurements
CHF5633 vs Poractant Alfa: Mean Difference (Final Values): 2.45 (95% CI -2.04 to 6.93), p = 0.282, Mixed model for repeated measurements
CHF5633 vs Poractant Alfa: Mean Difference (Final Values): 0.41 (95% CI -4.04 to 4.86), p = 0.854, Mixed model for repeated measurements

Primary outcome: Number of Patients With Bronchopulmonary Dysplasia and Mortality

Time frame: 36 weeks post menstrual age, Day 14 Post-Natal Age, Day 28 Post-Natal Age. Count of participants. Unit: Participants

Measure	CHF5633 n = 56	Poractant Alfa n = 57
36 week PMA Incidence of BPD (Yes)	31	32
36 week PMA Mortality/BPD	35	38
36 week PMA Mortality	4	6
Day 28 (PNA) Mortality	4	3
Day 14 (PNA) RDS-associated mortality	1	2

CHF5633 vs Poractant Alfa: Relative risk: 1.03 (95% CI 0.81 to 1.32), p = 0.811, Cochran-Mantel-Haenszel
CHF5633 vs Poractant Alfa: Relative risk: 1.00 (95% CI 0.81 to 1.25), p = 0.972, Cochran-Mantel-Haenszel
CHF5633 vs Poractant Alfa: Relative risk: 0.74 (95% CI 0.23 to 2.42), p = 0.619, Cochran-Mantel-Haenszel

Adverse events

Time frame: Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHF5633	20 of 59 (33.9%)	59 of 59 (100%)	4 of 59
Poractant Alfa	20 of 58 (34.5%)	58 of 58 (100%)	7 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32553868Ramanathan R, Biniwale M, Sekar K, Hanna N, Golombek S, Bhatia J, Naylor M, Fabbri L, Varoli G, Santoro D, Del Buono D, Piccinno A, Dammann CE. Synthetic Surfactant CHF5633 Compared with Poractant Alfa in the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter, Double-Blind, Randomized, Controlled Clinical Trial. J Pediatr. 2020 Oct;225:90-96.e1. doi: 10.1016/j.jpeds.2020.06.024. Epub 2020 Jun 14.
Individual participant dataSharing planned: No

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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.

Rangasamy Ramanathan, MD principal investigator

Division of Neonatology, Department of Pediatrics, LAC+USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, CA, USA

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHF5633 and Poractant alfa in people with Respiratory Distress Syndrome, Newborn, run by Chiesi Farmaceutici S.p.A. at 23 sites in United States.

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 5 inclusion and 10 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 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio (time frame: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7). The study lists 3 primary outcomes in all. 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 NCT02452476, 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 13 Aug 2021.