GATTEX was evaluated in a 6-month pediatric clinical study
In a 6-month study, 59 children aged 1 through 17 chose whether to receive GATTEX or standard of care (SOC).**
- 50 children who were treated with GATTEX were subsequently randomized in a double-blind manner to receive either 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26)
- The remaining 9 children received SOC
- Randomization to the GATTEX groups was stratified by age
- Prior to the study all the children were dependent on PS
The goal of the trial: To see if children treated with GATTEX achieved a reduction in weekly PS volume of at least 20% from baseline. The study also evaluated safety.
**In this clinical trial, SOC primarily referred to parenteral nutrition, and for many patients it also included enteral nutrition.
Characteristics of children in the beginning of the study
Tertiary Subtle
Demographics
People treated with GATTEX 0.05 mg/kg/day
Age
1-11 years
92%
12-17 years
8%
Male
73%
Primary Cause of SBS
Tertiary Subtle
Gastroschisis
54%
Midgut volvulus
23%
Necrotizing enterocolitis
12%
Intestinal atresia
4%
Hirschsprung’s disease
4%
Baseline characteristics
Tertiary Subtle
Mean remaining small intestine length
47 cm
Mean PS infusion volumes
60 mL/kg/day
Mean PS infusion time
7 days/week
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