AngioedemaPhase 2ACENCT01036659
Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
A Phase 2 study testing ecallantide - Kallikrein inhibitor that blocks the production of bradykinin in people with Angioedema, run by Bernstein, Jonathan A., M.D. at 3 sites in United States.
Trial summary
The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Angioedema
- What is being tested?
- ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
- Must currently be on an ACE inhibitor
- Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
- All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.
Who cannot join
- Participation in another investigational study within 30 days prior to enrollment
- Patients who improve on conventional (standard of care) therapy
- Patients previously treated with ecallantide
- Hypersensitivity to ecallantide
- Pregnancy or breast feeding
- Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
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- Patients receiving C-1 inhibitor as prophylaxis
- Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
- Receiving fresh frozen plasma within 3 days prior to enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
The Jewish Hospital
Cincinnati, Ohio, 45201
Jillian K Picard, RN, BSN, 513-558-0924, Jillian.picard@uc.edu
Sarah J Holmes, RN, BSN, 513-558-0924, Sarah.holmes@uc.edu
- Recruiting
Univeristy Hospital
Cincinnati, Ohio, 45219
Jillian K Picard, RN, BSN, 513-558-0924, Jillian.picard@uc.edu
Sarah J Holmes, RN, BSN, 513-558-0924, Sarah.holmes@uc.edu
- Recruiting
UC Physicians, Dpt of Internal Medicine, Division of Immunology
Cincinnati, Ohio, 45267
Jillian Picard, RN, 513-558-0924, jillian.picard@uc.edu
Sarah J. Holmes, RN, 513-558-0924, sarah.holmes@uc.edu
About this study
Official title: Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.
- Conditions
- Angioedema
- Being tested
- ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
- Keywords
- acute angiotensin converting enzyme inhibitor angioedema
- Medical subject headings
- Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ecallantide - Kallikrein inhibitor that blocks the production of bradykininDrug
subcutaneous dose of 30mg of ecallantide or placebo (three 10 mg SC injections at three different sites ((arms, legs, abdomen). Injections are not to be administered at the attack location.
| Study group | Role | What they receive |
|---|---|---|
| Ecallantide in conjunction with Conventional Therapy | Active comparator | Not described Receives: Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin |
| Conventional therapy and placebo | Placebo comparator | Not described Receives: Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin |
| Historical Evaluation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I.
Measured: 18 months
Secondary outcomes (1)
Time to meet objective discharge criteria, Physician assessment of angioedema improvement measured using the Symptom Complex Response Assessment at 2 hours post-treatment and 4 hours post-treatment.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bernstein, Jonathan A., M.D.
- Collaborators
- Dyax Corp.
- Investigators
- Jonathan A. Bernstein, M.D., Principal investigator, UC Physicians, Division of ImmunologyJoseph Moellman, MD, Principal investigator, UC Physicians, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036659
- Sponsor's protocol ID
- ACE Induced Angioedema
- Acronym
- ACE
- Status last verified
- Mar 2012
- First submitted
- 18 Dec 2009
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bernstein JA, Moellman JJ, Collins SP, Hart KW, Lindsell CJ. Effectiveness of ecallantide in treating angiotensin-converting enzyme inhibitor-induced angioedema in the emergency department. Ann Allergy Asthma Immunol. 2015 Mar;114(3):245-9. doi: 10.1016/j.anai.2014.12.007. Epub 2015 Jan 16.
PubMed 25601538
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
- ClinicalTrials.gov ID
- NCT01036659
- Acronym / sponsor ID
- ACE / ACE Induced Angioedema
- Conditions
- Angioedema
- Keywords
- acute angiotensin converting enzyme inhibitor angioedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bernstein, Jonathan A., M.D.
- Collaborators
- Dyax Corp.
- Study start
- May 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ecallantide in conjunction with Conventional Therapy | Active comparator | Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin |
| Conventional therapy and placebo | Placebo comparator | Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin |
| Historical Evaluation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
- Must currently be on an ACE inhibitor
- Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
- All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.
Key exclusion criteria (9 listed)
- Participation in another investigational study within 30 days prior to enrollment
- Patients who improve on conventional (standard of care) therapy
- Patients previously treated with ecallantide
- Hypersensitivity to ecallantide
- Pregnancy or breast feeding
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 |
|---|---|---|
| ecallantide - Kallikrein inhibitor that blocks the production of bradykininsubcutaneous dose of 30mg of ecallantide or placebo (three 10 mg SC injections at three different sites ((arms, legs, abdomen). Injections are not to be administered at the attack location. | Drug | Conventional therapy and placebo, Ecallantide in conjunction with Conventional Therapy |
Primary outcome
Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I.
Time frame: 18 months
1 secondary outcome
Time to meet objective discharge criteria, Physician assessment of angioedema improvement measured using the Symptom Complex Response Assessment at 2 hours post-treatment and 4 hours post-treatment.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Derived from this study: PubMed 25601538Bernstein JA, Moellman JJ, Collins SP, Hart KW, Lindsell CJ. Effectiveness of ecallantide in treating angiotensin-converting enzyme inhibitor-induced angioedema in the emergency department. Ann Allergy Asthma Immunol. 2015 Mar;114(3):245-9. doi: 10.1016/j.anai.2014.12.007. Epub 2015 Jan 16.
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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.
Jonathan A. Bernstein, M.D. principal investigator
UC Physicians, Division of Immunology
Joseph Moellman, MD principal investigator
UC Physicians, Department of Emergency Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ecallantide - Kallikrein inhibitor that blocks the production of bradykinin in people with Angioedema, run by Bernstein, Jonathan A., M.D. at 3 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jillian Picard, RN (513-558-0924, jillian.picard@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I. (time frame: 18 months). 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 NCT01036659, which also lists 1 linked publication.
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 9 Mar 2012.