Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks (CHANGE 3)

May 19, 2021 updated by: Shire

LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks

The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
        • Clinical Research Consultants, Inc
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Allergy and Immunology Associates
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Allergy and Asthma Clinic of Northwest Arkansas
    • California
      • Los Angeles, California, United States, 90095
        • UCLA-David Geffen School of Medicine
      • San Diego, California, United States, 92093
        • University of California, San Diego
      • San Jose, California, United States, 95117
        • Allergy and Asthma Associates of Santa Clara
      • Walnut Creek, California, United States, 94598
        • Allergy and Asthma Clinical Research, Inc
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Allergy and Asthma Center
      • Orlando, Florida, United States, 32826
        • Allergy and Asthma Center of East Orlando
      • Weston, Florida, United States, 33331
        • Cleveland Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Family Allergy and Asthma Center
      • Suwanee, Georgia, United States, 30024
        • Atlanta Allergy and Asthma Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University Consultants in Allergy & Immunology
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic
    • Kansas
      • Liberal, Kansas, United States, 67901
        • Private practice
      • Olathe, Kansas, United States, 66061
        • Olathe Medical Center
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
      • Louisville, Kentucky, United States, 40215
        • Family Asthma and Allergy Research Center
    • Maryland
      • Waldorf, Maryland, United States, 20602
        • Asthma Allergy and Sinus Center
      • Wheaton, Maryland, United States, 20902
        • Institute for Asthma and Allergy
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Grand Traverse Allergy
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • MeritCare Clinical Research
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Nevada Access to Research and Education Society
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ Asthma and Allergy Research Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Hastings-on-Hudson, New York, United States, 10706
        • Private practice
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Allergy Partners of East Carolina
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Legacy Pharma Research
      • Fargo, North Dakota, United States, 58122
        • MeritCare Clinical Research
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Childrens Hospital Clinical Research
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Allergy Clinic of Tulsa
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Medical Group
      • Lake Oswego, Oregon, United States, 97035
        • Allergy Asthma and Dermatology Research Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University
    • Texas
      • Dallas, Texas, United States, 75231
        • AARA Research Center
      • Galveston, Texas, United States, 77555-1083
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • University of Texas - Pediatric Pulmonary/Allergy and Immunology
      • San Antonio, Texas, United States, 78229
        • Allergy and Asthma Research Center
      • Woodville, Texas, United States, 75979
        • Tyler County Hospital
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Virginia Adult and Pediatric Allergy and Asthma
    • Washington
      • Spokane, Washington, United States, 99204
        • Marycliff Allergy Specialists
      • Tacoma, Washington, United States, 98405
        • Puget Sound Allergy, Asthma and Immunology
    • West Virginia
      • Parkersburg, West Virginia, United States, 26102
        • St. Joseph's Hospital/Cornerstone Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- History of at least 1 HAE attack per month or any history of laryngeal edema

In addition, this study was open to all subjects who:

  • Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B
  • Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed
  • Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up

  • Were excluded from LEVP2005-1 for any of the following reasons:

    • Pregnancy or lactation
    • Age less than 6 years
    • Narcotic addiction
    • Presence of anti-C1 inhibitor (C1INH) autoantibodies

  • Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:

    • Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
    • Had a known HAE-causing C1INH mutation, or
    • Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator

Exclusion Criteria:

  • History of allergic reaction to C1INH or other blood products
  • Participated in any other investigational drug study within the past 30 days other than those sponsored by Lev Pharmaceuticals
  • Received blood or a blood product in the past 60 days other than C1INH-nf

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Open-label C1INH-nf
1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.
Biological: C1 esterase inhibitor [human] (C1INH-nf)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of All HAE Attacks
Time Frame: Duration of the study
A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
Duration of the study

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antigenic C1 Inhibitor (C1INH) Serum Levels
Time Frame: Pre-infusion to 1 hour post-infusion
Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.
Pre-infusion to 1 hour post-infusion
Functional C1INH Serum Levels
Time Frame: Pre-infusion to 1 hour post-infusion
Change from pre-infusion to 1 hour post-infusion in functional C1INH serum levels. Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH).
Pre-infusion to 1 hour post-infusion
Complement C4 Serum Levels
Time Frame: Pre-infusion to 1 hour post-infusion
Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.
Pre-infusion to 1 hour post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LEVP2006-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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