A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire Human Genetic Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT00912093
First received: June 2, 2009
Last updated: April 18, 2013
Last verified: April 2013

June 2, 2009
April 18, 2013
June 2009
July 2012   (final data collection date for primary outcome measure)
Time to symptom relief for an acute attack, as assessed by the patient [ Time Frame: Patients monitored for a minimum of 8 hrs or until stable ] [ Designated as safety issue: No ]
Time to symptom relief for an acute attack, as assessed by the patient [ Time Frame: Patients monitored for 8 hrs or until stable ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00912093 on ClinicalTrials.gov Archive Site
  • Change in VAS score from pretreatment [ Time Frame: 2, 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
  • Evaluation of global outcome of treatment using symptom severity score (by patient and investigator) [ Time Frame: Up to 5 hours post-treatment ] [ Designated as safety issue: No ]
  • Assessment of global improvement(by patient and investigator) [ Time Frame: 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
  • Global assessment of symptoms (by investigator) [ Time Frame: 2, 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
  • Time(s) to initial symptom improvement and almost complete symptom relief [ Time Frame: Up to 5 days post-treatment ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Up to 14 days post-treatment ] [ Designated as safety issue: Yes ]
  • Time to reduction in symptom severity of laryngeal attacks [ Time Frame: Up to Day 5 post-treatment ] [ Designated as safety issue: No ]
  • Time to onset of symptom relief using VAS [ Time Frame: Patients monitored for a minimum of 8 hrs after first attack ] [ Designated as safety issue: No ]
  • Time to onset of symptom relief for first attack using composite VAS for non-laryngeal and mild-moderate laryngeal attacks [ Time Frame: Patients monitored a minimum of 8 hrs after first attack ] [ Designated as safety issue: No ]
  • Time to symptom relief using composite VAS for mild-moderate laryngeal attacks [ Time Frame: Patients monitored for a minimum of 8 hrs after first attack ] [ Designated as safety issue: No ]
  • Change in VAS score from pretreatment [ Time Frame: 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
  • Evaluation of global outcome of treatment using symptom severity score (by patient and investigator) [ Time Frame: Up to 12 hours post-treatment ] [ Designated as safety issue: No ]
  • Assessment of global improvement(by patient and investigator) [ Time Frame: 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
  • Global assessment of symptoms (by investigator) [ Time Frame: 4 and 8 hours post-treatment ] [ Designated as safety issue: No ]
  • Time(s) to initial symptom improvement and almost complete symptom relief [ Time Frame: Up to 5 days post-treatment ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Up to 14 days post-treatment ] [ Designated as safety issue: Yes ]
  • Time to reduction in symptom severity of laryngeal attacks [ Time Frame: Up to Day 5 post-treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
A Phase III Randomized, Double-Blind,Placebo-Controlled, Multicenter Study of Icatibant for Subcutaneous Injection in Patients With Acute Attacks of Hereditary Angioedema (HAE)

This study is being conducted to evaluate the efficacy of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hereditary Angioedema
  • Drug: Icatibant
    Single subcutaneous injection of icatibant, 30 mg
    Other Name: Firazyr
  • Drug: Placebo
    Single subcutaneous injection of matching placebo
  • Placebo Comparator: Placebo
    Single subcutaneous injection of matching placebo
    Intervention: Drug: Placebo
  • Experimental: Icatibant
    Single subcutaneous injection of icatibant, 30 mg
    Intervention: Drug: Icatibant

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study.

  1. The patient is ≥18 years old at the time of informed consent.
  2. The patient has a documented diagnosis of HAE type I or II. The diagnosis will be confirmed either by documented decreased C4 levels and/or immunogenic or functional C1-INH deficiency results (<50% of normal levels) consistent with HAE types I and II or by medical history.
  3. The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
  4. Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by investigator global assessment at pre-treatment assessments
  5. The patient must report at least 1 VAS score ≥ 30mm
  6. The patient 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 after the onset of the attack.
  7. Women of childbearing potential must have a negative urine pregnancy test and must use appropriate methods to prevent pregnancy during their participation in the study.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

  1. The patient has a diagnosis of angioedema other than HAE type I or II.
  2. The patient has received previous treatment with icatibant.
  3. The patient has participated in a clinical trial and has received treatment with another investigational medicinal product within the past 30 days.
  4. The patient has received treatment with any pain medication since the onset of the current angioedema attack.
  5. The patient has received replacement therapy (fresh frozen plasma [FFP], C1-INH products) less than 5 days (120 hours) from the onset of the current angioedema attack.
  6. The patient is receiving treatment with angiotensin converting enzyme (ACE) inhibitors.
  7. Evidence of coronary artery disease based on medical history or screening examination in particular unstable angina pectoris or severe coronary heart disease;
  8. The patient has a serious concomitant illness or condition that, in the opinion of the Investigator, would be a contraindication for participation in the trial.
  9. The patient is pregnant or breastfeeding.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Hungary,   Israel,   Romania,   Russian Federation,   South Africa,   Ukraine
 
NCT00912093
HGT-FIR-054
No
Shire Human Genetic Therapies, Inc.
Shire Human Genetic Therapies, Inc.
Not Provided
Study Director: Alan Kimura, M.D. Shire Human Genetic Therapies, Inc.
Shire Human Genetic Therapies, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP