Hereditary Angioedema (HAE)Phase 3NCT03888755
A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants
A Phase 3 study testing Icatibant in people with Hereditary Angioedema (HAE), run by Shire at 8 sites in Japan.
Trial summary
The objective of this study is to evaluate the efficacy, pharmacokinetics (PK), and safety of icatibant for the treatment of acute attacks in Japanese participants with type I or type II hereditary angioedema (HAE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Angioedema (HAE)
- What is being tested?
- Icatibant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 8 sitesJapan
- Study dates
- 18 Mar 2015to 12 Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant is in Japan and is Japanese; defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents.
- The participant is male or female and greater than or equal to (>=) 18 years of age at the time of informed consent.
- The participant has a confirmed diagnosis of hereditary angioedema (HAE) type I or II. Diagnosis may be based on historical data using the following criteria:
- Family history of angioedema
- Characteristic attack manifestations, recurrent attacks
- C1 esterase inhibitor (C1-INH) deficiency
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- In the absence of a family history of angioedema, exclusion of other forms of angioedema (example: acquired angioedema)
- If the participant does not have a confirmed diagnosis of HAE type I or II based on historical data, including C1-INH deficiency, the participant's diagnosis must be determined prior to treatment by C1-NH test results which demonstrate a quantitative and/or functional C1-INH deficiency.
- HAE type I: Low amount of C1-INH protein and low level of C1-INH activity; HAE type; II: Normal or increased amount of C1-INH protein and low level of C1-INH activity
- In the absence of a family history of angioedema, exclusion of other forms of angioedema based on a normal level of C1q.
- The current HAE attack must be in the cutaneous, abdominal, and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
- The attack must be moderate to severe for non-laryngeal and mild to moderate for laryngeal as determined by investigator global assessment at pretreatment (baseline).
- The participant commences treatment within 6 hours of the attack becoming at least mild (laryngeal) or moderate (non-laryngeal) in severity, but not more than 12 hours (h) after the onset of the attack. Note: for participant who present to the hospital/clinic with symptoms which have already progressed to at least moderate (non-laryngeal) or mild (laryngeal) severity, their duration can be estimated by the investigator through questioning of the participant.
- The participant (or the participant's parent/legal guardian, if applicable) has provided written informed consent which has been approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
- If the participant is an adult, be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed. OR
- If the participant is a minor (that is [i.e.] < 20 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (i.e., permission) for the minor to participate in the study before any study-specific procedures are performed; Assent will be obtained from minor participants.
- Females of childbearing potential must have a negative urine pregnancy test and must use medically acceptable methods to prevent pregnancy during their active participation in the study, (time from icatibant treatment of the acute attack to the follow-up visit at Day 7 [+3 days]), with the exception of those females who have had a total hysterectomy or bilateral oophorectomy, or who are 2 years post menopausal.
Who cannot join
- The participant will require an intervention to support the airway (example: intubation, tracheotomy, cricothyrotomy) due to the current attack of angioedema.
- The participant presents with an HAE attack with laryngeal/upper respiratory tract symptoms which are considered severe in the investigator's clinical judgment and in conjunction with the investigator global assessment and which may necessitate urgent care and/or impede the conduct of study efficacy assessments.
- The participant has a diagnosis of angioedema other than HAE (non-hereditary angioedema, example: acquired angioedema).
- The participant has received previous treatment with icatibant.
- The participant is enrolled in another clinical study that involves investigation or use of any investigational product (drug or device) within 30 days prior to study enrollment or at any time during the study.
- The participant has received treatment with any pain medication since the onset of the current angioedema attack.
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- The participant has received replacement therapy (C1-INH products, fresh frozen plasma [FFP]) < 5 days (120 hours) from the onset of the current angioedema attack.
- The participant is receiving treatment with angiotensin converting enzyme (ACE) inhibitors.
- The participant has evidence of coronary artery disease based on medical history at the screening examination or at pretreatment; example: unstable angina pectoris or severe coronary heart disease and congestive heart failure, that in the investigator's judgment would be a contraindication for participation in the trial (New York Heart Association [NYHA] class 3 and 4).
- The participant has a serious pre-existing condition or condition that, in the opinion of the investigator, would be a contraindication for participation in the trial.
- The participant is pregnant or breastfeeding.
- The participant is unable to understand the nature, scope, and possible consequences of the protocol, or is unlikely to comply with the protocol assessments, unable to return for follow up visits, or unlikely to complete the study for any reason.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Fukushima Medical University Hospital
Fukushima
Hiroshima University Hospital
Hiroshima
Kobe University Hospital
Kobe
Saiseikai Kumamoto Hospital
Kumamoto
Niigata City General Hospital
Niigata
Nihon University Itabashi Hospital
Tokyo
Tomakomai City Hospital
Tomakomai
Yokohama City University Hospital
Yokohama
About this study
Official title: An Open-Label Study of Icatibant in Japanese Subjects With Acute Attacks of Hereditary Angioedema.
The objective of this study is to evaluate the efficacy, pharmacokinetics (PK), and safety of icatibant for the treatment of acute attacks in Japanese participants with type I or type II hereditary angioedema (HAE).
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- Icatibant
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcatibantDrug
Participants will receive icatibant 30 mg SC injection in the abdominal area.
| Study group | Role | What they receive |
|---|---|---|
| Icatibant | Experimental | Participants with 1 acute non-laryngeal or laryngeal attack will receive a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that are at least 6 hours apart can be given for treatment of an attack if, within 48 hours of the initial treatment, there is insufficient relief or worsening of symptoms. Receives: Drug: Icatibant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset of Symptom Relief (TOSR)
The TOSR was defined as a 50 percent (%) reduction from the pre-treatment score in the 3-symptom composite VAS score for non-laryngeal attacks and 5-symptom composite VAS score for laryngeal attacks. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores were calculated as the average of VAS measurements for skin swelling, skin pain, and abdominal pain (3-symptom composite) for non-laryngeal attacks and for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks.
Measured: Baseline up to 120 hours post-treatment
Secondary outcomes (17)
Time to Onset of Primary Symptom Relief (TOSR-P)
Primary symptom relief was based on the participant-assessed VAS score for a single primary symptom (determined by edema location) and corresponds to a reduction by 31 mm at a pretreatment VAS of 100 mm and by 21 mm at a pretreatment VAS of 30 mm. If the primary symptom pretreatment VAS less than (<) 30 mm, then primary symptom relief was defined as 68% reduction from pretreatment. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The TOSR-P was calculated from the time of icatibant administration to the onset of primary symptom relief.
Measured: Baseline up to 120 hours post-treatment
Change From Baseline in the Composite Visual Analog Scale (VAS) Score
A VAS utilizes a scale consisting of a 100 mm horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores was calculated as the average of VAS measurements for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks and as the average of VAS measurements for skin swelling, skin pain and abdominal pain (3-symptom composite) for non-laryngeal attacks. Change from baseline in the composite VAS score was reported.
Measured: Baseline, 2, 4 and 8 hours post-treatment
Composite Symptom Score (SS) Assessed by Investigator
The investigator-assessed composite symptom score was calculated as an average of abdominal tenderness, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, and skin swelling (8 symptoms) for non-laryngeal attacks and the average of abdominal tenderness, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, skin swelling, dysphagia, voice change, breathing difficulties, stridor, and asphyxia (13 symptoms) for laryngeal attacks using the following 5-point scale 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). Here the composite SS assessed by investigator was reported.
Measured: 8 hours post dose
Composite Symptom Score (SS) Assessed by Participant
The participant-assessed composite symptom score was calculated as an average of abdominal pain, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, and skin swelling (8 symptoms) for non-laryngeal attacks and the average of abdominal pain, nausea, vomiting, diarrhea, skin pain, erythema,skin irritation, skin swelling, dysphagia and voice change (10 symptoms) for laryngeal attacks using the following 5-point scale 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). Here the composite SS assessed by participant was reported.
Measured: 8 hours post dose
Investigator Global Assessment
The investigator was made a global assessment (that is [i.e.] consideration of all abdominal symptoms combined, all cutaneous symptoms combined and/or all laryngeal symptoms combined) using the following 5-point scale, where the symptoms were scored from 0 for "absence of symptoms" to 4 for "very severe": 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities).
Measured: 2, 4 and 8 hours post dose
Time to Initial Symptom Improvement by Investigator
Time to initial symptom improvement was evaluated by the investigator; each were asked to record the time at which they perceived initial improvement of symptoms. Time to initial symptom improvement was calculated from the time of icatibant administration to the time reported by the investigator of initial improvement of symptoms.
Measured: Baseline up to 120 hours post-treatment
Time to Initial Symptom Improvement by Participants
Time to initial symptom improvement was evaluated by the participants; each were asked to record the time at which they perceived initial improvement of symptoms. Time to initial symptom improvement was calculated from the time of icatibant administration to the time reported by the participant of initial improvement of symptoms.
Measured: Baseline up to 120 hours post-treatment
Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score
Time to almost complete symptom relief was calculated from the time of icatibant administration to almost complete symptom relief. Almost complete symptom relief was determined retrospectively as the earliest of three consecutive non-missing measurements for which all VAS scores < 10 mm. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom.
Measured: Baseline up to 120 hours post-treatment
Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant
The Cmax was estimated by a population PK modeling approach. The Cmax of icatibant was reported.
Measured: Baseline, 0.75, 2 hours post-treatment
Area Under the Concentration-time Curve From 0 to 2 Hours (AUC0-2) After a Single Subcutaneous (SC) Administration of Icatibant
The AUC0-2 was estimated by a population PK modeling approach. The AUC0-2 of Icatibant was reported.
Measured: Baseline, 0.75, 2 hours post-treatment
Area Under the Concentration-time Curve From 0 to 4 Hours (AUC0-4) After a Single Subcutaneous (SC) Administration of Icatibant
The AUC0-4 was estimated by a population PK modeling approach. The AUC0-4 of Icatibant was reported.
Measured: Baseline, 0.75, 2 hours post-treatment
Area Under the Concentration-time Curve From 0 to 6 Hours (AUC0-6) After a Single Subcutaneous (SC) Administration of Icatibant
The AUC0-6 was estimated by a population PK modeling approach. The AUC0-6 of Icatibant was reported.
Measured: Baseline, 0.75, 2 hours post-treatment
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurred in any phase of a clinical study, whether or not considered investigational product related. The TEAEs were defined as all AEs occurred on or after the time of study drug administration.
Measured: From start of study drug administration to follow-up (up to 10 days)
Number of Participants With Injection Site Reactions Reported as Adverse Event (AE)
Number of participants with injection site reactions (erythema, swelling, cutaneous pain, burning sensation, itching/pruritus, and warm sensation) were reported.
Measured: From start of study drug administration to follow-up (up to 10 days)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Adverse Event (AE)
Clinical laboratory tests included serum chemistry, hematology, urinalysis and coagulation were assessed. Number of participants with clinically significant changes in clinical laboratory tests were reported.
Measured: From start of study drug administration to follow-up (up to 10 days)
Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Event (AE)
Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants with clinically significant changes in vital signs were reported.
Measured: From start of study drug administration to follow-up (up to 10 days)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Adverse Event (AE)
A standard 12-lead ECG was performed. The number of participants who reported clinically significant changes in ECGs were reported.
Measured: From start of study drug administration to follow-up (up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start18 Mar 2015
- Primary completion12 Feb 2016
- Study completion12 Feb 2016
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.
- Other trials for Hereditary Angioedema (HAE)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT03888755
- Sponsor's protocol ID
- SHP-FIR-301
- Status last verified
- May 2021
- First submitted
- 20 Mar 2019
- Last updated
- 3 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Icatibant in Japanese Subjects With Acute Attacks of Hereditary Angioedema.
- ClinicalTrials.gov ID
- NCT03888755
- Acronym / sponsor ID
- SHP-FIR-301
- Conditions
- Hereditary Angioedema (HAE)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- 12 Feb 2016 (actual)
- Study completion
- 12 Feb 2016 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Posted 8 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy, pharmacokinetics (PK), and safety of icatibant for the treatment of acute attacks in Japanese participants with type I or type II hereditary angioedema (HAE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icatibant | Experimental | Drug: IcatibantParticipants with 1 acute non-laryngeal or laryngeal attack will receive a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that are at least 6 hours apart can be given for treatment of an attack if, within 48 hours of the initial treatment, there is insufficient relief or worsening of symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The participant is in Japan and is Japanese; defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents.
- The participant is male or female and greater than or equal to (>=) 18 years of age at the time of informed consent.
- The participant has a confirmed diagnosis of hereditary angioedema (HAE) type I or II. Diagnosis may be based on historical data using the following criteria:
- If the participant does not have a confirmed diagnosis of HAE type I or II based on historical data, including C1-INH deficiency, the participant's diagnosis must be determined prior to treatment by C1-NH test results which demonstrate a quantitative and/or functional C1-INH deficiency.
- The current HAE attack must be in the cutaneous, abdominal, and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
Key exclusion criteria (12 listed)
- The participant will require an intervention to support the airway (example: intubation, tracheotomy, cricothyrotomy) due to the current attack of angioedema.
- The participant presents with an HAE attack with laryngeal/upper respiratory tract symptoms which are considered severe in the investigator's clinical judgment and in conjunction with the investigator global assessment and which may necessitate urgent care and/or impede the conduct of study efficacy assessments.
- The participant has a diagnosis of angioedema other than HAE (non-hereditary angioedema, example: acquired angioedema).
- The participant has received previous treatment with icatibant.
- The participant is enrolled in another clinical study that involves investigation or use of any investigational product (drug or device) within 30 days prior to study enrollment or at any time during the study.
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 |
|---|---|---|
| IcatibantParticipants will receive icatibant 30 mg SC injection in the abdominal area. | Drug | Icatibant |
Primary outcome
Time to Onset of Symptom Relief (TOSR)
Time frame: Baseline up to 120 hours post-treatment
The TOSR was defined as a 50 percent (%) reduction from the pre-treatment score in the 3-symptom composite VAS score for non-laryngeal attacks and 5-symptom composite VAS score for laryngeal attacks. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores were calculated as the average of VAS measurements for skin swelling, skin pain, and abdominal pain (3-symptom composite) for non-laryngeal attacks and for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks.
17 secondary outcomes
Time to Onset of Primary Symptom Relief (TOSR-P)
Time frame: Baseline up to 120 hours post-treatment
Change From Baseline in the Composite Visual Analog Scale (VAS) Score
Time frame: Baseline, 2, 4 and 8 hours post-treatment
Composite Symptom Score (SS) Assessed by Investigator
Time frame: 8 hours post dose
Composite Symptom Score (SS) Assessed by Participant
Time frame: 8 hours post dose
Investigator Global Assessment
Time frame: 2, 4 and 8 hours post dose
Time to Initial Symptom Improvement by Investigator
Time frame: Baseline up to 120 hours post-treatment
Time to Initial Symptom Improvement by Participants
Time frame: Baseline up to 120 hours post-treatment
Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score
Time frame: Baseline up to 120 hours post-treatment
Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant
Time frame: Baseline, 0.75, 2 hours post-treatment
Area Under the Concentration-time Curve From 0 to 2 Hours (AUC0-2) After a Single Subcutaneous (SC) Administration of Icatibant
Time frame: Baseline, 0.75, 2 hours post-treatment
Area Under the Concentration-time Curve From 0 to 4 Hours (AUC0-4) After a Single Subcutaneous (SC) Administration of Icatibant
Time frame: Baseline, 0.75, 2 hours post-treatment
Area Under the Concentration-time Curve From 0 to 6 Hours (AUC0-6) After a Single Subcutaneous (SC) Administration of Icatibant
Time frame: Baseline, 0.75, 2 hours post-treatment
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration to follow-up (up to 10 days)
Number of Participants With Injection Site Reactions Reported as Adverse Event (AE)
Time frame: From start of study drug administration to follow-up (up to 10 days)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Adverse Event (AE)
Time frame: From start of study drug administration to follow-up (up to 10 days)
Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Event (AE)
Time frame: From start of study drug administration to follow-up (up to 10 days)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Adverse Event (AE)
Time frame: From start of study drug administration to follow-up (up to 10 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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
8 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 Icatibant in people with Hereditary Angioedema (HAE), run by Shire at 8 sites in Japan.
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 17 inclusion and 12 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 3 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 8 sites in Japan. 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 8 Aug 2019). 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?
Time to Onset of Symptom Relief (TOSR) (time frame: Baseline up to 120 hours post-treatment). 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 3 Jun 2021.