Infantile HemangiomaPhase 2/3NCT01056341

Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

A Phase 2/3 study testing Propranolol in people with Infantile Hemangioma, run by Pierre Fabre Dermatology at 59 sites in 16 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 35 to 150 days
Conditions the study is for: Infantile Hemangioma
What is being tested?: Propranolol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 512 participants
Where: 59 sitesin 16 countries
Study dates: Jan 2010to Nov 2013
Phase: Phase 2/3
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 35 to 150 days
All sexes
No healthy volunteers
Child

Who may be able to join

Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm

Who cannot join

The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome with central nervous system involvement
The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
One or more of the following types of IH are present:
Life-threatening IH
Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.)

Show all 9Show fewer

Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures
The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)
LVEF (left ventricular systolic function) ≤40% and/or cardiomyopathy and/or hereditary arrhythmia disorder

Trial locations and contacts

59 sites in 16 countries.

Country

City, postcode or hospital

59 sites in 16 countries

United States10 sites

Dell Children's Medical center
Austin, Texas, 78723
State University of NY
Brooklyn, New York, 11203
Children's Memorial Hospital
Chicago, Illinois, 60614
University of California
Irvine, California, 92697-1385
Miami Children's Hospital
Miami, Florida, 33155
Oregon Health Sciences University
Portland, Oregon, 97239
Lucile Packard Children's Hospital
Redwood City, California, 94063-5334
Rady Children's Hospital
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104

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France10 sites

Hôpital Pellegrin-Enfants
Bordeaux, 33076
Hôpital Femme Mère Enfant
Lyon, 69677
CHU Hôtel Dieu
Nantes, 44093
Hôpital Archet 2
Nice, 06202
Hôpital Armand Trousseau
Paris, 75012
Hôpital Necker Enfants malades
Paris, 75015
Hopital Robert Debre - Consultation de Dermatologie
Paris, 75019
Hopital Nord-CHU St Etienne
Saint-Etienne, 42055
Hôpital des enfants
Toulouse, 31100
Hôpital Clocheville
Tours, 37044

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Spain6 sites

Servicio de Dermatologia del Hospital Infantil
A Coruña, 15006
Hospital Sant Pau de Barcelona
Barcelona, 08025
Hospital Universitario Infantil Niño Jesús
Madrid, 28009
Hospital La Paz
Madrid, 28056
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitario de Valencia
Valencia, 15006

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Romania5 sites

Spitalul Clinic Urgenta pentru Copii Grigore Alexandrescu
Bucharest, 011743
I.O.M.C Alfred Rusescu
Bucharest, 020395
Spitalul de Copii Dr. Victor Gomoiu
Bucharest, 022102
Spitalul Clinic de Urgenta pentu Copii Sf. Maria
Iași, 700309
Spitalul de Urgenta Copii, Louis Turcanu
Timișoara, 300011

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Germany4 sites

Universitätsklinikum Freiburg
Freiburg im Breisgau, D-79106
Kinderkrankenhaus Wilhelmstift
Hamburg, D-22149
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Kinderchirurgische Klinik Ludwig-Maximilians-Universität
München, D-30337

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Poland4 sites

Klinika Chirurgii i Urologii Dzieci i Mlodziezy Akademii Medycznej
Gdansk
University Children's Hospital
Krakow
Department of Pediatric Surgery and Oncology
Lodz
Klinika Onkologii, Centrum Zdrowia Dziecka
Warsaw

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Australia3 sites

Eastern Clinical Research Unit - Box Hill Hospital
Box Hill
Royal Children's Hospital
Melbourne
Sydney Children's Hospital
Randwick

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Peru3 sites

Clinica Internacional
Lima
Hospital Nacional Edgardo Rebagliati Martins
Lima
Instituto Nacional de Salud del Niño
Lima

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Russia3 sites

Medical University - Filatov Pediatric Hospital
Moscow
Medical Pediatric Academy
St-Peterburg
Neonatal Intensive Care Department
St-Peterburg

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Canada2 sites

CHU St.Justine
Montreal, H3T 1C5
The Hospital for Sick Children
Toronto, M5G 1H4

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Czechia2 sites

Children Dermatology
Brno
Clinic of Dermatovenerology, University
Prague

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Italy2 sites

University of Bari
Bari, 70124
Clinica Dermatologica
Milan, 20122

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New Zealand2 sites

Auckland Dermatology
Auckland
Waikato Clinical Research 2008 Ltd.
Hamilton

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Hungary1 site

Heim Pál Gyermekkórház,
Budapest

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Lithuania1 site

Vilnius University Children's Hospital
Vilnius

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Mexico1 site

Hospital Infantil de Mexico Federico Gomez
Mexico City

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About this study

Official title: A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).

There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

Read the detailed description

Primary objective The primary objective of this study is to identify the appropriate dose and duration of propranolol treatment and demonstrate its superiority over placebo based on the complete/nearly complete resolution of target IH at W24.

Conditions: Infantile Hemangioma
Being tested: Propranolol, Placebo
Keywords: Infantile Hemangioma, Propranolol
Medical subject headings: Hemangioma, Capillary

What participants receive

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

PropranololDrug
Propranolol (1 or 3 mg/kg/day for 3 or 6 months)
PlaceboDrug
Treatment with placebo for 6 months

Study groups in NCT01056341
Study group	Role	What they receive
Propranolol oral solution	Experimental	Not described Receives: Drug: Propranolol
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.
Measured: 6 months
Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.
Measured: 6 months

Secondary outcomes (1)

Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.
Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits
Measured: 6 months

Timeline

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

Jan 2010Nov 2013

First posted26 Jan 2010 (estimated)
Study startJan 2010
Primary completionMay 2012
Study completionNov 2013

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 (3)Papers the sponsor has linked to this study.
Other trials for Infantile HemangiomaStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 512 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01056341
Sponsor's protocol ID: V00400 SB 201 Study
Status last verified: Nov 2015
First submitted: 24 Jan 2010
Last updated: 10 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.
PubMed 18550886
Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.
PubMed 19706583
Leaute-Labreze C, Hoeger P, Mazereeuw-Hautier J, Guibaud L, Baselga E, Posiunas G, Phillips RJ, Caceres H, Lopez Gutierrez JC, Ballona R, Friedlander SF, Powell J, Perek D, Metz B, Barbarot S, Maruani A, Szalai ZZ, Krol A, Boccara O, Foelster-Holst R, Febrer Bosch MI, Su J, Buckova H, Torrelo A, Cambazard F, Grantzow R, Wargon O, Wyrzykowski D, Roessler J, Bernabeu-Wittel J, Valencia AM, Przewratil P, Glick S, Pope E, Birchall N, Benjamin L, Mancini AJ, Vabres P, Souteyrand P, Frieden IJ, Berul CI, Mehta CR, Prey S, Boralevi F, Morgan CC, Heritier S, Delarue A, Voisard JJ. A randomized, controlled trial of oral propranolol in infantile hemangioma. N Engl J Med. 2015 Feb 19;372(8):735-46. doi: 10.1056/NEJMoa1404710.
PubMed 25693013

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 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).
ClinicalTrials.gov ID: NCT01056341
Acronym / sponsor ID: V00400 SB 201 Study
Conditions: Infantile Hemangioma
Keywords: Infantile Hemangioma, Propranolol
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 512 participants (actual)
Lead sponsor: Pierre Fabre DermatologyIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: May 2012 (actual)
Study completion: Nov 2013 (actual)
First posted: 26 Jan 2010 (estimated)
Results: Posted 24 Jun 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Propranolol oral solution	Experimental	Drug: Propranolol
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 35 to 150 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm

Key exclusion criteria (9 listed)

The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome with central nervous system involvement
The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
One or more of the following types of IH are present:
The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)

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
PropranololPropranolol (1 or 3 mg/kg/day for 3 or 6 months)	Drug	Propranolol oral solution
PlaceboTreatment with placebo for 6 months	Drug	Placebo

Primary outcome

Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.
Time frame: 6 months
Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.
Time frame: 6 months

1 secondary outcome

Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.
Time frame: 6 months

Results and safety

Results posted to the registry on 24 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	55	19
Propranolol 1mg/kg/d 3 Months	99	63
Propranolol 1 mg/kg/d 6 Months	103	88
Propranolol 3 mg/kg/d 3 Months	101	65
Propranolol 3 mg/kg/d 6 Months	102	88

Primary outcome: Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.

Time frame: 6 months. Number. Unit: percentage of participants

Measure	Placebo n = 25	Propranolol 1mg/kg/d 3 Months n = 41	Propranolol 1 mg/kg/d 6 Months n = 40	Propranolol 3 mg/kg/d 3 Months n = 39	Propranolol 3 mg/kg/d 6 Months n = 43
Value	8.0	9.8	37.5	7.7	62.8

Placebo vs Propranolol 1mg/kg/d 3 Months vs Propranolol 1 mg/kg/d 6 Months vs Propranolol 3 mg/kg/d 3 Months vs Propranolol 3 mg/kg/d 6 Months: p < 0.0001, One-sided Z-tests

Population analysed: Among the 190 first randomized patients who entered the stage 1 of the study, 2 patients were not treated because of parent'/legal guardian's decision: 1 in the 1mg/kg/day 6 months arm and 1 in the 3 mg/kg/day 3 months arm.

Primary outcome: Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.

Time frame: 6 months. Number. Unit: percentage of participants

Measure	Placebo n = 55	Propranolol 3mg/kg/d 6 Months n = 101
Value	3.6	60.4

Placebo vs Propranolol 3mg/kg/d 6 Months: p < 0.0001, combination tests

Population analysed: After the interim analysis results, the Independent Committee recommendations was to continue the trial with the 3 mg/kg/day6 months arm and the placebo arm. 55 randomized and treated patients in the placebo arm and 102 randomized patients in the 3 mg/kg/day6 months arm,1 was not treated because no unit of the assigned treatment available on site.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
W24-treatment Period-safety Set-Placebo	3 of 55 (5.5%)	40 of 55 (72.7%)	Not reported
W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months	5 of 98 (5.1%)	88 of 98 (89.8%)	Not reported
W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months	3 of 102 (2.9%)	92 of 102 (90.2%)	Not reported
W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months	9 of 100 (9%)	92 of 100 (92%)	Not reported
W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months	5 of 101 (5%)	96 of 101 (95%)	Not reported
W72-follow-up Period of ex Placebo Group-safety Set	5 of 33 (15.2%)	27 of 33 (81.8%)	Not reported
W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set	6 of 85 (7.1%)	66 of 85 (77.6%)	Not reported
W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set	5 of 91 (5.5%)	70 of 91 (76.9%)	Not reported
W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set	5 of 87 (5.7%)	65 of 87 (74.7%)	Not reported
W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set	7 of 95 (7.4%)	75 of 95 (78.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18550886Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.
Background: PubMed 19706583Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.
Results publication: PubMed 25693013Leaute-Labreze C, Hoeger P, Mazereeuw-Hautier J, Guibaud L, Baselga E, Posiunas G, Phillips RJ, Caceres H, Lopez Gutierrez JC, Ballona R, Friedlander SF, Powell J, Perek D, Metz B, Barbarot S, Maruani A, Szalai ZZ, Krol A, Boccara O, Foelster-Holst R, Febrer Bosch MI, Su J, Buckova H, Torrelo A, Cambazard F, Grantzow R, Wargon O, Wyrzykowski D, Roessler J, Bernabeu-Wittel J, Valencia AM, Przewratil P, Glick S, Pope E, Birchall N, Benjamin L, Mancini AJ, Vabres P, Souteyrand P, Frieden IJ, Berul CI, Mehta CR, Prey S, Boralevi F, Morgan CC, Heritier S, Delarue A, Voisard JJ. A randomized, controlled trial of oral propranolol in infantile hemangioma. N Engl J Med. 2015 Feb 19;372(8):735-46. doi: 10.1056/NEJMoa1404710.

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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.

Christine Labreze, MD study chair

Hopital de Bordeaux

59 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Propranolol in people with Infantile Hemangioma, run by Pierre Fabre Dermatology at 59 sites in 16 countries.

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 1 inclusion and 9 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, France, Spain, Romania, Germany and 11 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Jun 2014). 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?

Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. (time frame: 6 months). 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 NCT01056341, which also lists 3 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 10 Dec 2015.