ShockPhase 1/2NeoCirc-001NCT03311178

Dobutamine in the Treatment of Haemodynamic Insufficiency in the Immediate Postnatal Period

A Phase 1/2 study testing Dobutamine in people with Shock, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages Up to 72 hours
Conditions the study is for: Shock
What is being tested?: Dobutamine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteSpain
Study dates: 30 May 2014to 10 Oct 2017
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 Up to 72 hours
All sexes
No healthy volunteers
Child

Who may be able to join

Target population for informed consent:
neonates 24 to 32+6 weeks´ gestation,
postnatal age <72 hours;
Infants eligible for circulatory failure pathway:
parental informed consent obtained;
The infants will be assessed, as per routine clinical practice, for clinical signs indicating infants at risk of poor perfusion, and will be recruited if they develop haemodynamic insufficiency defined as: either two or more of: (i) Mean blood pressure (MBP) < gestational age (GA)-1 mmHg (invasive/non-invasive, two readings 15 min apart); (ii) SVC flow < 51 ml/kg/min; (iii) capillary refill time (CRT) > 4 sec; (iv) Lactate > 4 mmol/l (v) Base excess <-9 mmol/l or: MBP < GA -5 mmHg (invasive/non-invasive, two readings 15 min apart)

Who cannot join

non-viability;
congenital hydrops or malformations likely to affect cardiovascular adaptation;
surgery planned within 72 hours of birth;
chromosomal anomalies;
informed consent form (ICF) not signed.

Trial locations and contacts

1 site in 1 country.

Spain1 site

La Paz University Hospital, Department of Neonatology
Madrid, 28046

Other trials in Spain

About this study

Official title: An International Multicentre Open-label Comparative Therapeutic Exploratory Trial to Investigate the Role of a New Neonatal Formulation of Dobutamine in the Treatment of Haemodynamic Insufficiency in the Immediate Postnatal Period

Haemodynamic insufficiency after birth is seen commonly in babies born prematurely and is associated with adverse outcomes. In current clinical practice, a combination of blood pressure and clinical signs is used to guide therapy. However, blood pressure is a poor surrogate of systemic and organ (brain) blood flow distribution during transitional circulation. This state is characterised by increased peripheral vascular resistance and increased afterload causing myocardial depression and impaired blood flow distribution in spite of 'normal' blood pressure. Echocardiography-Doppler (Echo-D) measurement of superior vena cava (SVC) flow has been proposed as a more clinically relevant marker of circulatory impairment shortly after birth than systemic hypotension. When there is low SVC flow, several small-scale clinical trials have suggested dobutamine as the optimal therapeutic option. However the associations between SVC flow and short- and long- term outcomes are not strong enough to allow SVC flow alone to be the basis for the inclusion of patients into a confirmatory trial to demonstrate the efficacy and safety of dobutamine.

NeoCirc-001 - The primary objective is to answer some important questions required for the design of a subsequent placebo-controlled trial (NeoCirc-003), which will evaluate the effectiveness of a new neonatal formulation of dobutamine to treat haemodynamic insufficiency in the first 72 hours after birth in babies born at less than 33 weeks' gestation. Observational data will be collected from this population with a view to determining the degree to which diagnostic measures influence treatment decisions. The primary outcome is death or worst cranial ultrasound (CUS) appearance at or before 36 weeks' gestation.

NeoCirc-001A - The primary objective is to estimate the elimination half-life, and consequently the time to steady-state of dobutamine in extremely premature neonates.

NeoCirc-001B - The primary objective is to construct a population pharmacokinetic pharmacodynamic model that will be validated using samples collected during the confirmatory trial (NeoCirc-003).

Conditions: Shock
Being tested: Dobutamine
Keywords: Shock, Preterm infant, Dobutamine
Medical subject headings: Shock, Premature Birth

What participants receive

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

DobutamineDrug
Infants who meet the definition of poor perfusion state will be treated at the discretion of the responsible physician following the standard local policies. The interventions will be dobutamine from a new neonatal formulation developed for NeoCirc and/or other treatments (including any other cardiovascular drug or volume replacement with normal saline).

Study groups in NCT03311178
Study group	Role	What they receive
Dobutamine	Experimental	Infants who meet the definition of poor perfusion state will be treated at the discretion of the responsible physician following the standard local policies. The interventions will be dobutamine from a new neonatal formulation developed for NeoCirc and/or other treatments (including any other cardiovascular drug or volume replacement with normal saline). Receives: Drug: Dobutamine

What is being measured

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

Mortality, or intraventricular haemorrhage (IVH) grades 3 or 4, or cystic and non-cystic periventricular leukomalacia (PVL), or porencephalic cysts, ventriculomegaly, or cerebellar haemorrhage.
A composite endpoint is defined as follows: treatment failure is when one of the following is true at or before gestational age 36 (+/-2 weeks), when all surviving patients will have a cranial ultrasound (CUS)-
1. Neonate dies, or
2. Intraventricular haemorrhage (IVH) grades 3 or 4, or
3. cystic and non-cystic periventricular leukomalacia (PVL), or
4. porencephalic cysts, ventriculomegaly, or cerebellar haemorrhage.
Measured: at 36 (+/-2 weeks) postmenstrual age
Half-life of the neonatal formulation of dobutamine.
NeoCirc-001A: Half-life of the neonatal formulation of dobutamine.
The first sample will be drawn after the end of the infusion, at the time when dobutamine ceases reaching the systemic circulation of the neonate, defined as time end (te). To calculate the end of infusion (te) the dead space used in each unit will be taken into account (see below). The second sample will be taken at different study time points after the end of infusion:
- 5 min after te
- 15 min after te
- 45 min after te
- 2 hours after te
- 6 hours after te Two infants will be allocated to each time point. Sampling times will be assigned randomly to the patients.
Measured: The first sample will be drawn after the end of the infusion, at the time when dobutamine ceases. The second sample will be taken at different study time points after the end of infusion (from 5 min to 6 hours).

Secondary outcomes (27)

Arterial blood pressure
Short-term outcomes of biomarkers for circulatory assessment while a patient is receiving cardiovascular support
Measured: First 72 hours of life (data collection every 9 ±3 hrs)
Capillary refill time
Short-term outcomes of biomarkers for circulatory assessment while a patient is receiving cardiovascular support
Measured: First 72 hours of life (data collection every 9 ±3 hrs)
Urine output
Short-term outcomes of biomarkers for circulatory assessment while a patient is receiving cardiovascular support
Measured: First 72 hours of life (data collection every 9 ±3 hrs)
Blood lactate concentration
Short-term outcomes of biomarkers for circulatory assessment while a patient is receiving cardiovascular support
Measured: First 72 hours of life (data collection every 9 ±3 hrs)
Base excess
Short-term outcomes of biomarkers for circulatory assessment while a patient is receiving cardiovascular support
Measured: First 72 hours of life (data collection every 9 ±3 hrs)
cerebral regional tissue oxygen saturation (rStO2)
Cerebral regional tissue oxygen saturation (rStO2) measured by means of near-infrared spectroscopy
Measured: First 72 hours of life (data collection every 6 ±1 hrs)
Background pattern
Background pattern measured by means of Amplitude-integrated electroencephalography (aEEG/EEG)
Measured: First 72 hours of life (data collection every 6 ±1 hrs)
Superior vena cava flow
Short-term outcomes of biomarkers for circulatory assessment while a patient is receiving cardiovascular support
Measured: First 72 hours of life (data collection every 9 ±3 hrs)
Right cardiac output
Short-term outcomes of biomarkers for circulatory assessment while a patient is receiving cardiovascular support
Measured: First 72 hours of life (data collection every 9 ±3 hrs)
Cerebral fractional oxygen extraction (FOE)
FOE= [peripheral oxygen saturation (SaO2)-rStO2] /SaO2
Measured: First 72 hours of life (data collection every 6 ±1 hrs)
Interburst interval (IBI)
Interburst interval (IBI) measured by means of Amplitude-integrated electroencephalography (aEEG/EEG)
Measured: First 72 hours of life (data collection every 6 ±1 hrs)
Discontinuity
Discontinuity measured by means of Amplitude-integrated electroencephalography (aEEG/EEG)
Measured: First 72 hours of life (data collection every 6 ±1 hrs)
Amplitude
The amplitude measured by means of aEEG/EEG
Measured: Fist 72 hours of life (data collection every 6 ±1 hrs)
Presence of abnormal transients
The presence of abnormal transients measured by means of aEEG/EEG
Measured: First 72 hours of life (data collection every 6 ±1 hrs)
Synchrony
The synchrony measured by means of aEEG/EEG
Measured: First 72 hours of life (data collection every 6 ±1 hrs)
Mortality
Measured: From birth to 36 (+/-2 weeks) postmenstrual age
Intraventricular haemorrhage 2-4
Measured: From birth to 36 (+/-2 weeks) postmenstrual age
Survival free of severe brain injury
Survival free of severe brain injury measured by means of cranial ultrasound studies
Measured: From birth to 36 (+/-2 weeks) postmenstrual age
Hypotension
Measured: From birth to 36 (+/-2 weeks) postmenstrual age
Hypertension
Measured: From birth to 36 (+/-2 weeks) postmenstrual age
Necrotizing enterocolitis
Measured: From birth to 36 (+/-2 weeks) postmenstrual age
Patent ductus (PDA)
Measured: From birth to 36 (+/-2 weeks) postmenstrual age
Retinopathy of prematurity
Measured: at 36 (+/-2 weeks) postmenstrual age
Chronic lung disease
Measured: at 36 (+/-2 weeks) postmenstrual age
Oxygen-dependency at discharge
Measured: At discharge
early infection
Measured: From birth to 72 hours after birth
Nosocomial infection
Measured: From birth to 36 (+/-2 weeks) postmenstrual age

Timeline

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

30 May 201410 Oct 2017

First posted17 Oct 2017
Study start30 May 2014
Primary completion13 Oct 2015
Study completion10 Oct 2017

Why it stopped: Substudy 001B is not required at this stage of the PIP

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for ShockStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03311178
Sponsor's protocol ID: Neocirculation 001
Acronym: NeoCirc-001
Status last verified: Oct 2017
First submitted: 27 May 2014
Last updated: 17 Oct 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Kluckow M, Evans N. Low superior vena cava flow and intraventricular haemorrhage in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F188-94. doi: 10.1136/fn.82.3.f188.
PubMed 10794784
Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
PubMed 10794783
Osborn DA, Paradisis M, Evans N. The effect of inotropes on morbidity and mortality in preterm infants with low systemic or organ blood flow. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD005090. doi: 10.1002/14651858.CD005090.pub2.
PubMed 17253539
Dempsey EM, Barrington KJ. Treating hypotension in the preterm infant: when and with what: a critical and systematic review. J Perinatol. 2007 Aug;27(8):469-78. doi: 10.1038/sj.jp.7211774.
PubMed 17653217

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?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An International Multicentre Open-label Comparative Therapeutic Exploratory Trial to Investigate the Role of a New Neonatal Formulation of Dobutamine in the Treatment of Haemodynamic Insufficiency in the Immediate Postnatal Period
ClinicalTrials.gov ID: NCT03311178
Acronym / sponsor ID: NeoCirc-001 / Neocirculation 001
Conditions: Shock
Keywords: Shock, Preterm infant, Dobutamine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Substudy 001B is not required at this stage of the PIP
Enrolment: 15 participants (actual)
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la PazUniversity, hospital or other
Collaborators: Hospital Universitario La Paz, Brighton and Sussex University Hospitals NHS Trust, University of Luebeck, Servicio Vasco de Salud Osakidetza, Spain, University of Liverpool, Vest Children´s Hospital, Germany, Datteln University Witten-Herdecke, Iuliu Hatieganu University of Medicine and Pharmacy, Semmelweis University, University of Pecs, Gazi University, Tufts Medical Center, Hannover Medical School, Onorach Clinical Dundee, Scotland, Proveca Limited Daresbury, England, Institut National de la Santé Et de la Recherche Médicale, France
Study start: 30 May 2014 (actual)
Primary completion: 13 Oct 2015 (actual)
Study completion: 10 Oct 2017 (actual)
First posted: 17 Oct 2017 (actual)
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.

NeoCirc-001A - The primary objective is to estimate the elimination half-life, and consequently the time to steady-state of dobutamine in extremely premature neonates.

NeoCirc-001B - The primary objective is to construct a population pharmacokinetic pharmacodynamic model that will be validated using samples collected during the confirmatory trial (NeoCirc-003).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dobutamine	Experimental	Drug: DobutamineInfants who meet the definition of poor perfusion state will be treated at the discretion of the responsible physician following the standard local policies. The interventions will be dobutamine from a new neonatal formulation developed for NeoCirc and/or other treatments (including any other cardiovascular drug or volume replacement with normal saline).

Who may qualify

Ages: Up to 72 hours
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

neonates 24 to 32+6 weeks´ gestation,
postnatal age <72 hours;
parental informed consent obtained;
The infants will be assessed, as per routine clinical practice, for clinical signs indicating infants at risk of poor perfusion, and will be recruited if they develop haemodynamic insufficiency defined as: either two or more of: (i) Mean blood pressure (MBP) < gestational age (GA)-1 mmHg (invasive/non-invasive, two readings 15 min apart); (ii) SVC flow < 51 ml/kg/min; (iii) capillary refill time (CRT) > 4 sec; (iv) Lactate > 4 mmol/l (v) Base excess <-9 mmol/l or: MBP < GA -5 mmHg (invasive/non-invasive, two readings 15 min apart)

Key exclusion criteria (5 listed)

non-viability;
congenital hydrops or malformations likely to affect cardiovascular adaptation;
surgery planned within 72 hours of birth;
chromosomal anomalies;
informed consent form (ICF) not signed.

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
DobutamineInfants who meet the definition of poor perfusion state will be treated at the discretion of the responsible physician following the standard local policies. The interventions will be dobutamine from a new neonatal formulation developed for NeoCirc and/or other treatments (including any other cardiovascular drug or volume replacement with normal saline).	Drug	Dobutamine

Primary outcome

Mortality, or intraventricular haemorrhage (IVH) grades 3 or 4, or cystic and non-cystic periventricular leukomalacia (PVL), or porencephalic cysts, ventriculomegaly, or cerebellar haemorrhage.
Time frame: at 36 (+/-2 weeks) postmenstrual age
A composite endpoint is defined as follows: treatment failure is when one of the following is true at or before gestational age 36 (+/-2 weeks), when all surviving patients will have a cranial ultrasound (CUS)- 1. Neonate dies, or 2. Intraventricular haemorrhage (IVH) grades 3 or 4, or 3. cystic and non-cystic periventricular leukomalacia (PVL), or 4. porencephalic cysts, ventriculomegaly, or cerebellar haemorrhage.
Half-life of the neonatal formulation of dobutamine.
Time frame: The first sample will be drawn after the end of the infusion, at the time when dobutamine ceases. The second sample will be taken at different study time points after the end of infusion (from 5 min to 6 hours).
NeoCirc-001A: Half-life of the neonatal formulation of dobutamine. The first sample will be drawn after the end of the infusion, at the time when dobutamine ceases reaching the systemic circulation of the neonate, defined as time end (te). To calculate the end of infusion (te) the dead space used in each unit will be taken into account (see below). The second sample will be taken at different study time points after the end of infusion: * 5 min after te * 15 min after te * 45 min after te * 2 hours after te * 6 hours after te Two infants will be allocated to each time point. Sampling times will be assigned randomly to the patients.

27 secondary outcomes

Arterial blood pressure
Time frame: First 72 hours of life (data collection every 9 ±3 hrs)
Capillary refill time
Time frame: First 72 hours of life (data collection every 9 ±3 hrs)
Urine output
Time frame: First 72 hours of life (data collection every 9 ±3 hrs)
Blood lactate concentration
Time frame: First 72 hours of life (data collection every 9 ±3 hrs)
Base excess
Time frame: First 72 hours of life (data collection every 9 ±3 hrs)
cerebral regional tissue oxygen saturation (rStO2)
Time frame: First 72 hours of life (data collection every 6 ±1 hrs)
Background pattern
Time frame: First 72 hours of life (data collection every 6 ±1 hrs)
Superior vena cava flow
Time frame: First 72 hours of life (data collection every 9 ±3 hrs)
Right cardiac output
Time frame: First 72 hours of life (data collection every 9 ±3 hrs)
Cerebral fractional oxygen extraction (FOE)
Time frame: First 72 hours of life (data collection every 6 ±1 hrs)
Interburst interval (IBI)
Time frame: First 72 hours of life (data collection every 6 ±1 hrs)
Discontinuity
Time frame: First 72 hours of life (data collection every 6 ±1 hrs)
Amplitude
Time frame: Fist 72 hours of life (data collection every 6 ±1 hrs)
Presence of abnormal transients
Time frame: First 72 hours of life (data collection every 6 ±1 hrs)
Synchrony
Time frame: First 72 hours of life (data collection every 6 ±1 hrs)
Mortality
Time frame: From birth to 36 (+/-2 weeks) postmenstrual age
Intraventricular haemorrhage 2-4
Time frame: From birth to 36 (+/-2 weeks) postmenstrual age
Survival free of severe brain injury
Time frame: From birth to 36 (+/-2 weeks) postmenstrual age
Hypotension
Time frame: From birth to 36 (+/-2 weeks) postmenstrual age
Hypertension
Time frame: From birth to 36 (+/-2 weeks) postmenstrual age
Necrotizing enterocolitis
Time frame: From birth to 36 (+/-2 weeks) postmenstrual age
Patent ductus (PDA)
Time frame: From birth to 36 (+/-2 weeks) postmenstrual age
Retinopathy of prematurity
Time frame: at 36 (+/-2 weeks) postmenstrual age
Chronic lung disease
Time frame: at 36 (+/-2 weeks) postmenstrual age
Oxygen-dependency at discharge
Time frame: At discharge
early infection
Time frame: From birth to 72 hours after birth
Nosocomial infection
Time frame: From birth to 36 (+/-2 weeks) postmenstrual age

Results and safety

The study was stopped early (reason given: Substudy 001B is not required at this stage of the PIP). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
Background: PubMed 10794784Kluckow M, Evans N. Low superior vena cava flow and intraventricular haemorrhage in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F188-94. doi: 10.1136/fn.82.3.f188.
Background: PubMed 10794783Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
Background: PubMed 17253539Osborn DA, Paradisis M, Evans N. The effect of inotropes on morbidity and mortality in preterm infants with low systemic or organ blood flow. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD005090. doi: 10.1002/14651858.CD005090.pub2.
Background: PubMed 17653217Dempsey EM, Barrington KJ. Treating hypotension in the preterm infant: when and with what: a critical and systematic review. J Perinatol. 2007 Aug;27(8):469-78. doi: 10.1038/sj.jp.7211774.
Individual participant dataSharing planned: Undecided

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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.

Adelina Pellicer, MD PhD study chair

SERMAS La Paz University Hospital

Heike Rabe, MD PhD study director

Brighton and Sussex University Hospitals (BSUH)

Fernando Cabañas, MD PhD principal investigator

Servicio Madrileño de Salud (SERMAS)

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dobutamine in people with Shock, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.

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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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 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 was stopped early (reason given: Substudy 001B is not required at this stage of the PIP). Results are not available in the source record.

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?

Mortality, or intraventricular haemorrhage (IVH) grades 3 or 4, or cystic and non-cystic periventricular leukomalacia (PVL), or porencephalic cysts, ventriculomegaly, or cerebellar haemorrhage. (time frame: at 36 (+/-2 weeks) postmenstrual age). The study lists 2 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 NCT03311178, which also lists 4 linked publications.

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 Oct 2017.