Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005838

Trial Description

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Title

A Phase 3, Multicenter, Randomized, Single-Blind, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Intravenous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Prevention of Angioedema Attacks in Children 6 to 11 Years of Age With Hereditary Angioedema

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units
and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent
angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).

Secondary Objectives - To assess the safety and tolerability, characterize the
pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose
levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005838
  •   2015/04/24
  •   2014/01/30
  •   no
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Secondary IDs

  •   NCT02052141  (ClinicalTrials.gov)
  •   0624-301  (ViroPharma)
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Health Condition or Problem studied

  •   Hereditary Angioedema
  •   D84.1 -  Defects in the complement system
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Interventions/Observational Groups

  •   Biological: CINRYZE
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Other
  •   Prevention
  •   Crossover
  •   III
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Primary Outcome

- Number of angioedema attacks in each treatment period; time frame: 12 weeks

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Secondary Outcome

- Number of subjects with adverse events by dose group; time frame: 12 weeks
- Change from baseline in C1 inhibitor (C1 INH) and C4 concentrations during each treatment period; time frame: Pre-dose to 1 hour post-dose at Visit 1, Week 6, and Week 12
- Number of subjects with C1 INH antibodies; time frame: 28 weeks

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Germany
  •   Italy
  •   Mexico
  •   Romania
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/02/27
  •   12
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   11   Years
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Additional Inclusion Criteria

- Diagnosis of Type I or Type II HAE.

- History of angioedema attacks.

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Exclusion Criteria

- History of bleeding or clotting abnormality.

- Diagnosis of acquired angioedema or known to have C1 INH antibodies.

- History of allergic reaction to C1 esterase inhibitor or other blood products.

- Receipt of any experimental agents other than those required for prevention or
treatment of angioedema attacks within 30 days prior to screening.

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Addresses

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    • ViroPharma
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    • ViroPharma
    • Martino Laurenzi, MD, MPH 
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    • ViroPharma
    • Martino Laurenzi, MD, MPH 
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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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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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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 .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.