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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 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.

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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

Sponsor

Shire

245 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01095510

The ClinicalTrials.gov registry entry for NCT01095510 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 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 (86% 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 1 intervention - of which CINRYZE is the first listed.

NCT01095510 reports 11 study locations spanning 7 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.