Trial · NCT04654351
A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema
NCT04654351, Phase 3, Completed, Takeda; results first posted 2022-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema. Trials, record NCT04654351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04654351
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema
- NCT number
- NCT04654351
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hereditary Angioedema
- Interventions
- TAK-667
- First posted
- 2020-12-04
- Last updated
- 2022-03-29
- Results first posted
- 2022-03-29
- Limitations and caveats
- Due to the low number of participants enrolled, the efficacy and pharmacokinetic data were not summarized to avoid risk of identification of the participant, only safety data was summarized.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAE) | Up to approximately 6 months | An adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A treatment-emergent adverse event (TEAE) was defined as any adverse event occurring after the start of Icatibant administration of the treatment period. |
| Primary | Number of Participants With Injection Site Reactions | Postdose, up to Day 8 | Injection sites were examined for erythema, swelling, cutaneous pain, burning sensation, itching/pruritus, and warm sensation. Data for injection site reactions were collected separately from general reports of AEs. As pre-defined in the protocol, an injection site reaction not meeting SAE criteria was not required to be reported additionally as an AE. |
| Secondary | Number of Participants Who Experienced at Least One TEAE Related to Resting 12-lead Electrocardiogram | Up to approximately 6 months | An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was defined as any AE occurring after the start of Icatibant administration of the Treatment Period. A resting 12-lead ECG was recorded and reported for participants shifts from within normal limits at baseline to abnormal, but not clinically significant, or abnormal and clinically significant after study drug administration. |
| Secondary | Number of Participants Who Experienced at Least One TEAE Related to Vital Sign | Up to approximately 6 months | An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was defined as any AE occurring after the start of Icatibant administration of the Treatment Period. Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (beats per minute \[bpm\]). |
| Secondary | Number of Participants Who Experienced at Least One TEAE Related to Clinical Laboratory Parameters | Up to approximately 6 months | An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was defined as any AE occurring after the start of Icatibant administration of the Treatment Period. The laboratory parameters included hematology, serum chemistries, and urinalysis. |
| Secondary | Number of Participants Who Experience at Least One TEAE Related to Clinically Significant Changes in Reproductive Hormones | Up to approximately 6 months | An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was defined as any AE occurring after the start of Icatibant administration of the Treatment Period. Blood samples were collected to assess follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone in females, and FSH, LH, and testosterone in males. |
| Secondary | Number of Participants Who Reported Presence of Anti-icatibant Antibodies | Up to approximately 6 months | Serum samples for immunogenicity testing were collected for determination of anti-icatibant antibodies. If hypersensitivity was observed, it was reported as an AEs of special interest. An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. |
| Secondary | Time to Onset of Symptom Relief With Investigator-Rated Symptom Scores Assessed by Investigator | Baseline, and post dose on Day 1 | The time to onset of symptom relief, defined as the duration of time in hours from the time of icatibant administration to the earliest time at which at least a 20% improvement is observed in the average post-treatment score with no worsening of any single component score. Investigator-rated symptom score was used for assessment and scoring of cutaneous, abdominal, and laryngeal symptoms of acute HAE attacks related to daily activities. The score ranged from 0 to 4 and each number of scores meant the following: 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). |
| Secondary | Time to Onset of Symptom Relief With Faces Pain Scale-Revised (FPS-R) Scores for Participants of 4 Years Age and Older | Baseline, and post dose on Day 1 | The time to onset of symptom relief, defined as the duration of time in hours from the time of icatibant administration to the earliest time at which the post-treatment score improved by at least 1 level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). |
| Secondary | Time to Onset of Symptom Relief by Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale Assessed by Investigator for Participants of Younger Than 4 Years Age | Baseline, and post dose on Day 1 | The time to onset of symptom relief, defined as the earliest time at which a 20% improvement is observed in the total post-treatment score. Participants of younger than 4 years age underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC compartmental pain scale. Each of the 5 categories were scored from 0 to 2. Face(F): 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); Legs(L): 0 (normal position/relaxed) - 2 (kicking/legs drawn up); Activity(A): 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); Cry(C): 0 (No cry \[awake/asleep\]) - 2 (crying steadily/screams/sobs or frequent complaints); Consolability(C): 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAE) | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Injection Site Reactions | Postdose, up to Day 8 | Safety analysis set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced at Least One TEAE Related to Resting 12-lead Electrocardiogram | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One TEAE Related to Vital Sign | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One TEAE Related to Clinical Laboratory Parameters | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experience at Least One TEAE Related to Clinically Significant Changes in Reproductive Hormones | Up to approximately 6 months | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Reported Presence of Anti-icatibant Antibodies | Up to approximately 6 months | Safety analysis set was defined as all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Onset of Symptom Relief With Investigator-Rated Symptom Scores Assessed by Investigator | Baseline, and post dose on Day 1 | Full analysis set included all participants who received at least 1 dose of study drug. | hours | MEDIAN |
| SECONDARY | Time to Onset of Symptom Relief With Faces Pain Scale-Revised (FPS-R) Scores for Participants of 4 Years Age and Older | Baseline, and post dose on Day 1 | Full analysis set included all participants who received at least 1 dose of study drug. | hours | MEDIAN |
| SECONDARY | Time to Onset of Symptom Relief by Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale Assessed by Investigator for Participants of Younger Than 4 Years Age | Baseline, and post dose on Day 1 | As there were no participants between 2 to \<4 years of age enrolled in this study, data was not collected for this outcome measure. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAE) | TAK-667 10-30 mg | 0 | Participants | ||
| Number of Participants With Injection Site Reactions | TAK-667 10-30 mg | 2 | percentage of participants | ||
| Number of Participants Who Experienced at Least One TEAE Related to Resting 12-lead Electrocardiogram | TAK-667 10-30 mg | 0 | Participants | ||
| Number of Participants Who Experienced at Least One TEAE Related to Vital Sign | TAK-667 10-30 mg | 0 | Participants | ||
| Number of Participants Who Experienced at Least One TEAE Related to Clinical Laboratory Parameters | TAK-667 10-30 mg | 0 | Participants | ||
| Number of Participants Who Experience at Least One TEAE Related to Clinically Significant Changes in Reproductive Hormones | TAK-667 10-30 mg | 0 | Participants | ||
| Number of Participants Who Reported Presence of Anti-icatibant Antibodies | TAK-667 10-30 mg | 0 | Participants | ||
| Time to Onset of Symptom Relief With Investigator-Rated Symptom Scores Assessed by Investigator | TAK-667 10-30 mg | NA | Full Range 0.9 to 1.0 | hours | |
| Time to Onset of Symptom Relief With Faces Pain Scale-Revised (FPS-R) Scores for Participants of 4 Years Age and Older | TAK-667 10-30 mg | NA | Full Range 0.9 to 1.0 | hours | |
| Number of Participants Who Were Treated With Rescue Medication During Study | TAK-667 10-30 mg | 0 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAK-667 10-30 mg | 2 | |
| Overall Study | COMPLETED | TAK-667 10-30 mg | 2 | |
| Overall Study | NOT COMPLETED | TAK-667 10-30 mg | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAK-667 10-30 mg | 0 | 2 |
| Total, other adverse events | TAK-667 10-30 mg | 0 | 2 |
| Total, serious adverse events | TAK-667 10-30 mg | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04654351
GET https://conductscience.org/api/trials/v1/NCT04654351/results?page=2