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Pancreatic Enzyme

Phase 2

Short Bowel Syndrome | Small molecule | Gastrointestinal |AbbVie Inc.|Last Updated: Mar 20, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03097029Use of Pancreatic Enzymes in Short Bowel SyndromePHASE2 COMPLETED 16Mar 24, 2017Feb 1, 2019Mar 20, 20201 United States
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Study Endpoints
Primary Endpoints
Change in Coefficient of Fat Absorption
Up to 10 days

Coefficient of fat absorption (CFA) measures the amount of fat excreted in the stool compared to how much fat was consumed over the course of 72 hours. This is a measure of fat absorption. CFA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CFA values at each timepoint was the primary outcome.

Secondary Endpoints
Change in the Coefficient of Nitrogen Absorption
Up to 10 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pancreatic EnzymesEXPERIMENTALAll subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.
Interventions
NameTypeDescription
Pancreatic EnzymeDRUGAll subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.
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Eligibility Criteria
Age Range4 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * history of a small bowel resection with subsequent dependence on parenteral nutrition for at least three months * age 4 years to 65 years * usual state of health for the past two weeks with no medication changes * able to participate in a study for about four weeks with four s...

Countries:United States
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Competitive Landscape -Short Bowel Syndrome 9 trials