Acute ACE-induced AngioedemaPhase 3NCT01843530
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
A Phase 3 study testing Berinert, Clemastin and Cortisone acetate in people with Acute ACE-induced Angioedema, run by Technical University of Munich at 4 sites in Germany.
Trial summary
This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema. This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute ACE-induced Angioedema
- What is being tested?
- Berinert, Clemastin and Cortisone acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 4 sitesGermany
- Study dates
- Nov 2013to 30 Sep 2019
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent to participate in the study and ability to fulfil all study requirements
- Male or female patients aged >=18 years
- Patients with ACE induced angioedema (grade II-III) with imminent airway obstruction admitted to an Emergency department
- Patient is being treated with ACEi
- Patient must have acute angioedema attack caused by ACEi
- Treatment should be administered within 10 hours after onset of the angioedema
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- Patients with angioedema of the head and/or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)
- Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country
- Signed patient information consent form
Who cannot join
- Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic edema, anaphylaxis, insect bite, trauma, abscess, local inflammation, local tumour, post-operative or post-radiogenic edema, salivary gland disorders
- Participation in a clinical study in the past 30 days
- Patients with simultaneous itchiness of skin (acute urticaria)
- Patients with a history of angioedema before taking ACEi
- History of hypersensitivity to any of the study drugs or medicine with a similar chemical structure.
- Pregnancy and/or breastfeeding
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- Mental retardation of the patient with restriction of general judgment and awareness
- History of drug abuse (including alcohol and alcoholic liver disorders)
- Potentially unreliable patients
- Patients who are not suitable for the study in the opinion of the investigator
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Kath. Klinikum Bochum, Med. Klinik III
Bochum, 44787
Ludwig-Maximilian-Universität
München, 81377
Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik
München, 81675
Universitätsklinikum Ulm, HNO
Ulm, 89070
About this study
This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema.
This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.
- Conditions
- Acute ACE-induced Angioedema
- Being tested
- Berinert, Clemastin, Cortisone acetate, NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerinertDrug
ClemastinDrug
Cortisone acetateDrug
NaClDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Cortisone, Clemastin + BERINERT Receives: Drug: Berinert; Drug: Clemastin; Drug: Cortisone acetate |
| Group 2 | Placebo comparator | Cortinsone, Clemastin + NaCl Receives: Drug: Clemastin; Drug: Cortisone acetate; Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of resolution
Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment.
Measured: 07/2013 until 12/2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startNov 2013
- Primary completion5 Oct 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ACE-induced AngioedemaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Murat Bas, Dr., Principal investigator, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843530
- Sponsor's protocol ID
- BER-1272-0058-I
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2013
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
- ClinicalTrials.gov ID
- NCT01843530
- Acronym / sponsor ID
- BER-1272-0058-I
- Conditions
- Acute ACE-induced Angioedema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 Apr 2013 (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.
This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema.
This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Berinert, Drug: Clemastin, Drug: Cortisone acetateCortisone, Clemastin + BERINERT |
| Group 2 | Placebo comparator | Drug: Clemastin, Drug: Cortisone acetate, Drug: NaClCortinsone, Clemastin + NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent to participate in the study and ability to fulfil all study requirements
- Male or female patients aged >=18 years
- Patients with ACE induced angioedema (grade II-III) with imminent airway obstruction admitted to an Emergency department
- Patient is being treated with ACEi
- Patient must have acute angioedema attack caused by ACEi
Key exclusion criteria (10 listed)
- Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic edema, anaphylaxis, insect bite, trauma, abscess, local inflammation, local tumour, post-operative or post-radiogenic edema, salivary gland disorders
- Participation in a clinical study in the past 30 days
- Patients with simultaneous itchiness of skin (acute urticaria)
- Patients with a history of angioedema before taking ACEi
- History of hypersensitivity to any of the study drugs or medicine with a similar chemical structure.
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 |
|---|---|---|
| Berinert | Drug | Group 1 |
| Clemastin | Drug | Group 1, Group 2 |
| Cortisone acetate | Drug | Group 1, Group 2 |
| NaCl | Drug | Group 2 |
Primary outcome
time of resolution
Time frame: 07/2013 until 12/2014
Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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.
Murat Bas, Dr. principal investigator
Klinikum rechts der Isar
4 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 Berinert, Clemastin and Cortisone acetate in people with Acute ACE-induced Angioedema, run by Technical University of Munich at 4 sites in Germany.
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 9 inclusion and 10 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 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time of resolution (time frame: 07/2013 until 12/2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.