Hereditary AngioedemaPhase 3CHANGE 3NCT00462709
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
A Phase 3 study testing C1 esterase inhibitor [human] (C1INH-nf) in people with Hereditary Angioedema, run by Shire at 48 sites in United States.
Trial summary
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- C1 esterase inhibitor [human] (C1INH-nf)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 48 sitesUnited States
- Study dates
- 27 Jun 2006to 31 Mar 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
Family Allergy and Asthma Center
Atlanta, Georgia, 30342
MeritCare Clinical Research
Bemidji, Minnesota, 56601
Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, 72712
Legacy Pharma Research
Bismarck, North Dakota, 58501
Massachusetts General Hospital
Boston, Massachusetts, 02114
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101
University Consultants in Allergy & Immunology
Chicago, Illinois, 60612
Nationwide Childrens Hospital Clinical Research
Columbus, Ohio, 43205
AARA Research Center
Dallas, Texas, 75231
Oregon Medical Group
Eugene, Oregon, 97401
Welborn Clinic
Evansville, Indiana, 47713
MeritCare Clinical Research
Fargo, North Dakota, 58122
Allergy and Asthma Center
Fort Lauderdale, Florida, 33334
University of Texas Medical Branch
Galveston, Texas, 77555-1083
Allergy Partners of East Carolina
Greenville, North Carolina, 27858
Private Practice
Hastings-on-Hudson, New York, 10706
Penn State University
Hershey, Pennsylvania, 17033
Clinical Research Consultants, Inc
Hoover, Alabama, 35216
University of Texas - Pediatric Pulmonary/Allergy and Immunology
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Allergy Asthma and Dermatology Research Center
Lake Oswego, Oregon, 97035
Nevada Access to Research and Education Society
Las Vegas, Nevada, 89102
Private Practice
Liberal, Kansas, 67901
UCLA-David Geffen School of Medicine
Los Angeles, California, 90095
Family Asthma and Allergy Research Center
Louisville, Kentucky, 40215
Winthrop University Hospital
Mineola, New York, 11501
Mount Sinai School of Medicine
New York, New York, 10029
UMDNJ Asthma and Allergy Research Center
Newark, New Jersey, 07103
Olathe Medical Center
Olathe, Kansas, 66061
Allergy and Asthma Center of East Orlando
Orlando, Florida, 32826
St. Joseph's Hospital/Cornerstone Healthcare
Parkersburg, West Virginia, 26102
Virginia Adult and Pediatric Allergy and Asthma
Richmond, Virginia, 23229
Allergy and Asthma Research Center
San Antonio, Texas, 78229
University of California, San Diego
San Diego, California, 92093
Allergy and Asthma Associates of Santa Clara
San Jose, California, 95117
Allergy and Immunology Associates
Scottsdale, Arizona, 85251
Marycliff Allergy Specialists
Spokane, Washington, 99204
St. Louis University School of Medicine
St Louis, Missouri, 63110
Atlanta Allergy and Asthma Clinic
Suwanee, Georgia, 30024
Puget Sound Allergy, Asthma and Immunology
Tacoma, Washington, 98405
Montefiore Medical Center
The Bronx, New York, 10461
Grand Traverse Allergy
Traverse City, Michigan, 49684
Allergy Clinic of Tulsa
Tulsa, Oklahoma, 74133
Asthma Allergy and Sinus Center
Waldorf, Maryland, 20602
Allergy and Asthma Clinical Research, Inc
Walnut Creek, California, 94598
Cleveland Clinic
Weston, Florida, 33331
Institute for Asthma and Allergy
Wheaton, Maryland, 20902
Tyler County Hospital
Woodville, Texas, 75979
About this study
Official title: 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.
- Conditions
- Hereditary Angioedema
- Being tested
- C1 esterase inhibitor [human] (C1INH-nf)
- Keywords
- Hereditary angioedema, C1 esterase inhibitor (human)
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1 esterase inhibitor [human] (C1INH-nf)Biological
| Study group | Role | What they receive |
|---|---|---|
| Open-label C1INH-nf | Experimental | 1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days. Receives: Biological: C1 esterase inhibitor [human] (C1INH-nf) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of All HAE Attacks
A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
Measured: Duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study start27 Jun 2006
- Primary completion31 Mar 2009
- Study completion31 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hereditary AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462709
- Sponsor's protocol ID
- LEVP2006-4
- Acronym
- CHANGE 3
- Status last verified
- May 2021
- First submitted
- 17 Apr 2007
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
PubMed 36326435Baker JW, Craig TJ, Riedl MA, Banerji A, Fitts D, Kalfus IN, Uknis ME. Nanofiltered C1 esterase inhibitor (human) for hereditary angioedema attacks in pregnant women. Allergy Asthma Proc. 2013 Mar-Apr;34(2):162-9. doi: 10.2500/aap.2013.34.3645.
PubMed 23484892Lumry W, Manning ME, Hurewitz DS, Davis-Lorton M, Fitts D, Kalfus IN, Uknis ME. Nanofiltered C1-esterase inhibitor for the acute management and prevention of hereditary angioedema attacks due to C1-inhibitor deficiency in children. J Pediatr. 2013 May;162(5):1017-22.e1-2. doi: 10.1016/j.jpeds.2012.11.030. Epub 2013 Jan 11.
PubMed 23312695Zuraw BL, Busse PJ, White M, Jacobs J, Lumry W, Baker J, Craig T, Grant JA, Hurewitz D, Bielory L, Cartwright WE, Koleilat M, Ryan W, Schaefer O, Manning M, Patel P, Bernstein JA, Friedman RA, Wilkinson R, Tanner D, Kohler G, Gunther G, Levy R, McClellan J, Redhead J, Guss D, Heyman E, Blumenstein BA, Kalfus I, Frank MM. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):513-22. doi: 10.1056/NEJMoa0805538.
PubMed 20818886
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00462709
- Acronym / sponsor ID
- CHANGE 3 / LEVP2006-4
- Conditions
- Hereditary Angioedema
- Keywords
- Hereditary angioedema, C1 esterase inhibitor (human)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2006 (actual)
- Primary completion
- 31 Mar 2009 (actual)
- Study completion
- 31 Mar 2009 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 3 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label C1INH-nf | Experimental | Biological: C1 esterase inhibitor [human] (C1INH-nf)1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- History of at least 1 HAE attack per month or any history of laryngeal edema
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C1 esterase inhibitor [human] (C1INH-nf) | Biological | Open-label C1INH-nf |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36326435Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
- Derived from this study: PubMed 23484892Baker JW, Craig TJ, Riedl MA, Banerji A, Fitts D, Kalfus IN, Uknis ME. Nanofiltered C1 esterase inhibitor (human) for hereditary angioedema attacks in pregnant women. Allergy Asthma Proc. 2013 Mar-Apr;34(2):162-9. doi: 10.2500/aap.2013.34.3645.
- Derived from this study: PubMed 23312695Lumry W, Manning ME, Hurewitz DS, Davis-Lorton M, Fitts D, Kalfus IN, Uknis ME. Nanofiltered C1-esterase inhibitor for the acute management and prevention of hereditary angioedema attacks due to C1-inhibitor deficiency in children. J Pediatr. 2013 May;162(5):1017-22.e1-2. doi: 10.1016/j.jpeds.2012.11.030. Epub 2013 Jan 11.
- Derived from this study: PubMed 20818886Zuraw BL, Busse PJ, White M, Jacobs J, Lumry W, Baker J, Craig T, Grant JA, Hurewitz D, Bielory L, Cartwright WE, Koleilat M, Ryan W, Schaefer O, Manning M, Patel P, Bernstein JA, Friedman RA, Wilkinson R, Tanner D, Kohler G, Gunther G, Levy R, McClellan J, Redhead J, Guss D, Heyman E, Blumenstein BA, Kalfus I, Frank MM. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):513-22. doi: 10.1056/NEJMoa0805538.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C1 esterase inhibitor [human] (C1INH-nf) in people with Hereditary Angioedema, run by Shire at 48 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of All HAE Attacks (time frame: Duration of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00462709, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.