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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01386658
Registration number
NCT01386658
Ethics application status
Date submitted
28/06/2011
Date registered
1/07/2011
Date last updated
8/06/2021
Titles & IDs
Public title
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
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Scientific title
A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents With Hereditary Angioedema
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Secondary ID [1]
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2011-003825-81
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Secondary ID [2]
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HGT-FIR-086
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hereditary Angioedema (HAE)
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Blood
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0
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - icatibant
Experimental: Icatibant - Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg
Treatment: Drugs: icatibant
Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant
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Assessment method [1]
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Time to peak concentration (Tmax) of a single SC dose of icatibant was reported.
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Timepoint [1]
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Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
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Primary outcome [2]
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Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant
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Assessment method [2]
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Maximum plasma concentration (Cmax) of a single SC dose of icatibant was reported.
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Timepoint [2]
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Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
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Primary outcome [3]
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Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant
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Assessment method [3]
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Total plasma clearance (CL/F) of a single SC dose of icatibant was reported.
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Timepoint [3]
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Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
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Primary outcome [4]
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Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant
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Assessment method [4]
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Area under the plasma concentration-time curve from time zero to 4 hours post-dose (AUC0-4) of a single SC dose of icatibant was reported.
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Timepoint [4]
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Pre-dose; 0.25, 0.5, 0.75, 1, 2, and 4 hours post-dose on Day 1
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Primary outcome [5]
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Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours Post-dose (AUC0-t) of a Single Subcutaneous (SC) Dose of Icatibant
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Assessment method [5]
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Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC0-t) of a single SC dose of icatibant was reported.
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Timepoint [5]
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Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
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Primary outcome [6]
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Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant
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Assessment method [6]
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Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of a single SC dose of icatibant was reported.
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Timepoint [6]
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Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
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Primary outcome [7]
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Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant
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Assessment method [7]
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Volume of distribution (Vz/F) of a single SC dose of icatibant was reported.
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Timepoint [7]
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Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
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Primary outcome [8]
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Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant
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Assessment method [8]
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Elimination half-life (t1/2) of a single SC dose of icatibant was reported.
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Timepoint [8]
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Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
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Primary outcome [9]
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Number of Participants With Clinically Significant Changes in Vital Signs
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Assessment method [9]
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Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants who reported clinically significant changes in vital signs were reported.
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Timepoint [9]
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Pre-dose up to 97 days post-dose
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Primary outcome [10]
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Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
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Assessment method [10]
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A standard 12-lead ECG was performed after 10 minutes at rest when the participant was seated or supine following treatment. The number of participants who reported clinically significant changes in ECGs were reported.
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Timepoint [10]
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6 - 8 hours post-dose on Day 1
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Primary outcome [11]
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Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations
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Assessment method [11]
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Clinical laboratory evaluations included clinical chemistry (including liver function tests), hematology, urinalysis. The number of participants who reported clinically significant changes in clinical laboratory evaluations were reported.
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Timepoint [11]
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Pre-dose up to 97 days post-dose
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Primary outcome [12]
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Number of Participants Who Reported Presence of Anti-icatibant Antibodies
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Assessment method [12]
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The number of participants who reported anti-icatibant antibodies were reported.
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Timepoint [12]
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Pre-dose up to 97 days post-dose
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Primary outcome [13]
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Number of Participants With Adverse Events (AEs)
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Assessment method [13]
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An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in a clinical study, whether or not considered investigational product related.
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Timepoint [13]
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From the start of study drug administration up to 97 days post-dose
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Primary outcome [14]
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Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 1
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Assessment method [14]
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The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occured after initial icatibant administration was reported.
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Timepoint [14]
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1 h post-dose on Day 1 up to 9 days post-dose
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Primary outcome [15]
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Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 2 and 3
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Assessment method [15]
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The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occurred after subsequent icatibant administration by study-site personnel (health care practitioner [HCP] administration) or by caregiver/self (caregiver administration) was reported. In the below table, E-2 refers to icatibant exposure 2 and E-3 refers to icatibant exposure 3.
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Timepoint [15]
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1 h post-dose up to 9 days post-dose
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Primary outcome [16]
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Number of Participants With Clinically Significant Changes in Reproductive Hormones
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Assessment method [16]
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Reproductive hormone levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone in females, and FSH, LH, and testosterone in males were measured. The number of participants with clinically significant changes in reproductive hormones was reported.
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Timepoint [16]
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Pre-dose up to 97 days post-dose
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Secondary outcome [1]
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Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1
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Assessment method [1]
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The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20 percent (%) improvement in the average post-treatment symptom score with no worsening of any single component score for the initial icatibant exposure. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of hereditary angioedema (HAE) 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) and 4=very severe (very severe interference with daily activities). TOSR for participants who received initial icatibant administration was reported.
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Timepoint [1]
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From start of study drug administration up to 8.5 hours post-dose
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Secondary outcome [2]
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Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3
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Assessment method [2]
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The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20% improvement in the composite (or average) post-treatment symptom score with no worsening of any single component score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.
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Timepoint [2]
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From start of study drug administration up to 12 hours post-dose
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Secondary outcome [3]
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Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1
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Assessment method [3]
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The TOSR was defined as the earliest time at which the post-treatment score improved by at least one 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). TOSR for participants who received initial icatibant administration was reported.
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Timepoint [3]
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From start of study drug administration up to 52 hours post-dose
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Secondary outcome [4]
0
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Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3
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Assessment method [4]
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The TOSR was defined as the earliest time at which the post-treatment score improved by at least one 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). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.
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Timepoint [4]
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From start of study drug administration up to 28 hours post-dose
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Secondary outcome [5]
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Time to Onset of Symptom Relief (TOSR) for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores
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Assessment method [5]
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The TOSR was defined as the earliest time at which a 20% improvement was seen in the total post-treatment score. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was 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.
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Timepoint [5]
0
0
From start of study drug administration up to 8.5 hours post-dose
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Secondary outcome [6]
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Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1
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Assessment method [6]
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Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received initial icatibant administration was reported.
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Timepoint [6]
0
0
From start of study drug administration up to 8.5 hours post-dose
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Secondary outcome [7]
0
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Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3
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Assessment method [7]
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Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.
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Timepoint [7]
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From start of study drug administration up to 12 hours post-dose
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Secondary outcome [8]
0
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Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1
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Assessment method [8]
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Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of 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). Time to minimum symptom for participants who received initial icatibant administration was reported.
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Timepoint [8]
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From start of study drug administration up to 52 hours post-dose
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Secondary outcome [9]
0
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Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3
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Assessment method [9]
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0
Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of 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). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.
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Timepoint [9]
0
0
From start of study drug administration up to 28 hours post-dose
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Secondary outcome [10]
0
0
Time to Minimum Symptom for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores
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Assessment method [10]
0
0
Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which the total post-treatment score improved to zero. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. (F) Face: 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); (L) Legs: 0 (normal position/relaxed) - 2 (kicking/legs drawn up); (A) Activity: 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); (C) Cry: 0 (No cry [awake/asleep]) - 2 (crying steadily/screams/sobs or frequent complaints); (C) Consolability: 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.
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Timepoint [10]
0
0
From start of study drug administration up to 8.5 hours post-dose
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Secondary outcome [11]
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Time to Use of Rescue Medication for the Treatment of Symptoms of the Hereditary Angioedema (HAE) Attack Following Study Drug Administration
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Assessment method [11]
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Rescue medication was any medication used after the administration of icatibant which, in the opinion of the investigator, was immediately necessary to alleviate acute symptoms which are judged by the investigator as resultant from the current HAE attack. Time to first use of rescue medication prior to the onset of symptom relief was calculated from the time of study drug administration to the first use of rescue medication prior to the onset of symptom relief. This analysis was not performed since as per protocol, "This analysis will only be performed if there are at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief".
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Timepoint [11]
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0
From the start of study drug administration up to 52 hours post-dose
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Secondary outcome [12]
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0
Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 1
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Assessment method [12]
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0
The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours postdose were reported.
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Timepoint [12]
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From 2 hours post-dose to 4 hours post-dose
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Secondary outcome [13]
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0
Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 2 and 3
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Assessment method [13]
0
0
The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours post-dose were reported.
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Timepoint [13]
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From 2 hours post-dose to 4 hours post-dose
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Eligibility
Key inclusion criteria
1. Two through <18 years of age at the time of first HAE attack.
- Prepubertal and pubertal/postpubertal subjects experiencing and acute cutaneous,
abdominal, or laryngeal HAE attack treated with icatibant as part of this study.
- Pubertal/postpubertal subjects with HAE who are treated with icatibant, but not
during an attack.
2. Documented diagnosis of HAE Type I or II.
3. Informed consent (and subject assent as appropriate) signed by the subject's
parent(s)or legal guardian(s).
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Minimum age
2
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Diagnosis of angioedema other than HAE.
2. Participation in another clinical trial that involves the use of any investigational
product (drug or device)within 30 days prior to study enrollment or at any time during
the study.
3. Any known factor/disease that might interfere with the treatment compliance, study
conduct,or result interpretation.
4. Congenital or acquired cardiac anomalies that interfere significantly with cardiac
function.
5. Treatment with ACE inhibitors within 7 days prior to treatment.
6. Use of hormonal contraception within the 90 days prior to treatment.
7. Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone)
within the 90 days prior to treatment.
8. Pregnancy or breastfeeding.
9. A physical condition that interferes with pubertal status determination.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/01/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/03/2018
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
0
0
Campbelltown Hospital - Campbelltown
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Recruitment postcode(s) [1]
0
0
2560 - Campbelltown
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Louisiana
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Maryland
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Massachusetts
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Missouri
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Ohio
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Oklahoma
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Oregon
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Pennsylvania
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Texas
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Country [12]
0
0
Austria
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State/province [12]
0
0
Graz
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Country [13]
0
0
Canada
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State/province [13]
0
0
Ontario
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Country [14]
0
0
Colombia
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State/province [14]
0
0
Cundinamarca
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Country [15]
0
0
Germany
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State/province [15]
0
0
Frankfurt
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Country [16]
0
0
Germany
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State/province [16]
0
0
Mainz
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Country [17]
0
0
Germany
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State/province [17]
0
0
Walldorf
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Country [18]
0
0
Hungary
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State/province [18]
0
0
Budapest
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Country [19]
0
0
Israel
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State/province [19]
0
0
Haifa
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Country [20]
0
0
Israel
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State/province [20]
0
0
Tel Aviv
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Country [21]
0
0
Israel
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State/province [21]
0
0
Tel Hashomer
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Country [22]
0
0
Italy
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State/province [22]
0
0
Naples
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Country [23]
0
0
Spain
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State/province [23]
0
0
Madrid
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Country [24]
0
0
Spain
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State/province [24]
0
0
Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Shire
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Summary
Brief summary
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the
Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single
subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with
Hereditary Angioedema (HAE) during an initial acute attack.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01386658
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Contacts
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Takeda
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01386658
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