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NCT02052141 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema

A Phase 3 study of Hereditary Angioedema (HAE), sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
12
Enrollment target
8
Study locations

NCT02052141 is a Phase 3 study of Hereditary Angioedema (HAE) that has completed, run by Shire. The registered enrollment target is 12 participants, below the 66-participant average among 7 other Hereditary Angioedema (HAE) trials with a reported enrollment target (82% lower). The trial reports 8 study locations across 4 states.

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The verdict

NCT02052141, a Phase 3 study of Hereditary Angioedema (HAE), has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
12 participants
Enrollment target
8
Study locations

Study Summary

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.

Conditions Studied

Hereditary Angioedema (HAE)

Interventions

  • BIOLOGICAL CINRYZE 500
  • BIOLOGICAL CINRYZE 1000

Study Locations (8)

Other

  • Klinikum der J.W. Goethe Universitat - Frankfurt
  • HZRM Hamophilie Zentrum Rhein Main GmbH - Mörfelden-Walldorf
  • Tel Aviv Sourasky Medical Center - Tel Aviv
  • Instituto Nacional de Pediatria - Mexico City
  • Clinical County Hospital Mures - Târgu Mureş

Colorado

  • Asthma and Allergy Associates, P.C - Colorado Springs

Nevada

  • Nevada Access to Research and Education Society - Las Vegas

Oregon

  • Oregon Allergy Associates - Eugene

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2014-03-20
Est. Completion 2017-05-04
Phase Phase 3

Sponsor

Shire

245 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02052141

The ClinicalTrials.gov registry entry for NCT02052141 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 66-participant average among 7 other Hereditary Angioedema (HAE) trials with a reported enrollment target (82% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hereditary Angioedema (HAE) appearing as the primary indexed condition, and to 2 interventions - of which CINRYZE 500 is the first listed.

NCT02052141 reports 8 study locations spanning 4 distinct geographic areas - top geographies include Other, Colorado, Nevada.

Frequently Asked Questions

What is clinical trial NCT02052141 about?

NCT02052141 is a clinical study titled "Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema". 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...

What is the current status of trial NCT02052141?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2014-03-20. Estimated completion is 2017-05-04.

What conditions does trial NCT02052141 study?

This clinical trial studies the following conditions: Hereditary Angioedema (HAE).

What interventions are being tested in trial NCT02052141?

The interventions under investigation include: CINRYZE 500 (BIOLOGICAL), CINRYZE 1000 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02052141?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02052141 being conducted?

This trial has 8 study locations across Colorado, Nevada, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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