Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

• Body Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  
• Height [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  
• Stool Frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  
• Stool Consistency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  
• Subject's Acceptance of Treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.
  
  

• Number of subjects with adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  
• Vital Signs [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  
• Physical Examination [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  An evaluation of the body and its functions using inspection, palpation (feeling with the hands), percussion (tapping with the fingers), and auscultation (listening).
  
  
• Safety Laboratory Values [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  (hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)
  
  

A prospective open-label, multi-center study evaluating safety and tolerability of Creon Micro in pediatric subjects from at least one month to less than four years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis (CF). Referring to the European Medicines Agency (EMEA) pediatric age criteria for the purpose of the study, subjects are categorized as infants and toddlers (< 2 years) and children, (2 years to < 4 years). In total, 40 subjects will be enrolled (20 subjects in each age subgroup). Subjects receive their prescribed pancreatic enzyme supplementation at the individual dose until start of treatment with Creon Micro, if the subjects were on pancreatic enzyme supplementation before start of the study. Subjects will be treated with Creon Micro during the study. The treatment duration is 3 months.