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NCT01095510 · ClinicalTrials.gov registry record · Phase 2

CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12

A Phase 2 study of Hereditary Angioedema (HAE), sponsored by Shire.

Completed
Registry status
Phase 2
Development phase
9
Enrollment target
11
Study locations

NCT01095510: Completed Phase 2 study of Hereditary Angioedema (HAE), sponsored by Shire.

NCT01095510 is a Phase 2 study of Hereditary Angioedema (HAE) that has completed, run by Shire. The registered enrollment target is 9 participants, below the 66-participant average among 7 other Hereditary Angioedema (HAE) trials with a reported enrollment target (86% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01095510, a Phase 2 study of Hereditary Angioedema (HAE), has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 2
Development phase
9 participants
Enrollment target
11
Study locations

Study Summary

The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and tolerability following IV administration of CINRYZE in this study population.

Conditions Studied

Hereditary Angioedema (HAE)

Interventions

  • BIOLOGICAL CINRYZE

Study Locations (11)

Other

  • Charité Universitätsmedizin Berlin, Dept. of Dermatology and Allergy - Berlin
  • Klinikum rechts der Isar, Technical University Munich, ENT Clinic - Munich
  • Semmelweis University, Allergy and Angioedema Outpatients Clinic, Kútvölgyi Clinical Center - Budapest

Oregon

  • Allergy & Asthma Research Group - Eugene
  • Baker Allergy, Asthma and Dermatology Research Center, LLC - Lake Oswego

Texas

  • AARA Research Center - Dallas
  • Allergy and Asthma Research Center, P.A. - San Antonio

Colorado

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

Florida

  • University of South Florida Asthma, Allergy and Immunology Clinical Research Unit - Tampa

Maryland

  • Institute for Asthma and Allergy, PC - Chevy Chase

Washington

  • Marycliff Allergy Specialists - Spokane

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2010-06-02
Est. Completion 2012-04-17
Phase Phase 2
Shire

245 total trials

What the finished NCT01095510 record still lists

NCT01095510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 66-participant average among 7 other Hereditary Angioedema (HAE) trials with a reported enrollment target (86% lower).

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

NCT01095510 lists 11 locations in 7 states (Other, Oregon, Texas).

Frequently Asked Questions

What is clinical trial NCT01095510 about?

NCT01095510 is a clinical study titled "CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12". The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary...

What is the current status of trial NCT01095510?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2010-06-02. Estimated completion is 2012-04-17.

What conditions does trial NCT01095510 study?

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

What interventions are being tested in trial NCT01095510?

The interventions under investigation include: CINRYZE (BIOLOGICAL).

Who is sponsoring clinical trial NCT01095510?

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

Where is trial NCT01095510 being conducted?

This trial has 11 study locations across Colorado, Florida, Maryland, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01095510, the US trial registry maintained by the National Library of Medicine. NCT01095510 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.