Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003785

Trial Description

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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).

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00003785
  •   2012/05/04
  •   2010/01/24
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01056341  (ClinicalTrials.gov)
  •   V00400 SB 201 Study  (Pierre Fabre Dermatology)
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Health Condition or Problem studied

  •   Infantile Hemangioma
  •   D18.0 -  Haemangioma, any site
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Interventions/Observational Groups

  •   Drug: Propranolol
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II-III
  •   [---]*
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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

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Secondary Outcome

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

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Countries of Recruitment

  •   United States
  •   Australia
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Lithuania
  •   Mexico
  •   New Zealand
  •   Peru
  •   Poland
  •   Romania
  •   Russian Federation
  •   Spain
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2010/01/31
  •   450
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   35   Days
  •   150   Days
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Additional Inclusion Criteria

- 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

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Exclusion Criteria

- 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.)

- 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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Pierre Fabre Dermatology
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    • Hopital de Bordeaux
    • Christine Labreze, MD 
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    •   [---]*
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    • Hopital de Bordeaux
    • Christine Labreze, MD 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/01
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Trial Publications, Results and other Documents

  •   Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. No abstract available.; 18550886
  •   Sans V, Dumas de la Roque E, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taïeb A, Léauté-Labrèze C. Propranolol for Severe Infantile Hemangiomas: Follow-Up Report. Pediatrics. 2009 Aug 10; [Epub ahead of print]; 19706583
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.