A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema

• Pharmacokinetic (PK) Profile after a single SC injection [ Time Frame: Administration through 48 hours ] [ Designated as safety issue: No ]
  PK parameter estimates will include, where appropriate: actual icatibant and metabolite concentrations at each sampling time, time to peak concentration (Tmax), actual peak (Cmax) and minimum (Cmin) concentrations, clearance (CL/F), actual area under the plasma concentration-time-curve (AUC0-last and AUC0-inf), mean residence time (MRT), volume of distribution at steady state (Vss/F) and elimination half-life (t1/2).
  
  
• Safety of a single SC dose of icatibant [ Time Frame: Treatment through day 90 ] [ Designated as safety issue: Yes ]
  Safety will be assessed by standard criteria including physical examination, vital signs, clinical laboratory evaluations, recording of concomitant medications, and monitoring of Adverse Events (AEs).
  
  

• Efficacy of a single SC dose of icatibant [ Time Frame: Treatment through 8 hours ] [ Designated as safety issue: No ]
  Efficacy will be assessed using both investigator- and subject-reported outcomes,depending on the subject's age.
  
  

Study HGT-FIR-086 is planned to enroll up to 36 subjects who are from 2 through 17 years of age and who present with an acute cutaneous, abdominal, or laryngeal HAE attack. After treatment for an initial attack, further open-label treatment with icatibant may be offered to subjects contingent upon having been treated previously and presenting with a subsequent acute cutaneous, abdominal, or laryngeal attack of HAE at least 7 days after prior treatment. Open-label treatment will continue until at least 15 pubertal/postpubertal subjects have been treated with icatibant for a total of 3 attacks each. Tolerability and safety evaluations will be performed at each subsequent icatibant-treated attack as for the initial treated attack.

The planned duration of active participation for subjects who present with an initial attack of acute HAE will consist of treatment with a single subcutaneous injection of icatibant on Day 1 through follow up at 90. The period of active participation for prepubertal subjects will be approximately 90 days and for pubertal/postpubertal subjects it will be approximately 270 days with each active period separated by periods of inactive participation.