Trial Outcomes & Findings for rHGH and Intestinal Permeability in Intestinal Failure (NCT NCT01380366)

Results Overview

Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

(Visit 1) Baseline to (Visit 2) 28-31 days after baseline

Results posted on

2016-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Zorptive Subjects Patients consent to rHGH and Intestinal Permeability in Intestinal Failure Study
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

rHGH and Intestinal Permeability in Intestinal Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Consented to be Given rHGH n=15 Participants Patients given growth hormone (rHGH) for their short bowel syndrome.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	50.1 years STANDARD_DEVIATION 15.16 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: (Visit 1) Baseline to (Visit 2) 28-31 days after baseline

Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.

Outcome measures

Outcome measures
Measure	Patients Experiencing Decrease in Concentration of Sucralose n=7 Participants A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).	7 participants

SECONDARY outcome

Timeframe: (Visit 1) Baseline, (Visit 2) 28-31 days after baseline, then at regularly scheduled follow-up clinic visits for two years from Month 3 through Month 24

Following completion of Visit 2, study staff will obtain results of liver injury/function tests (ALT, Aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALK or ALP), GGT) from the medical record from each routine clinical exam from Month 3 through Month 24. Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.

Outcome measures

Outcome measures
Measure	Patients Experiencing Decrease in Concentration of Sucralose n=7 Participants A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.	7 participants

Adverse Events

Patients Consented to be Given rHGH

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients Consented to be Given rHGH n=15 participants at risk Patients given growth hormone (rHGH) for their short bowel syndrome.
Blood and lymphatic system disorders Hospitalization for Escherichia coli Infection	6.7% 1/15 • Number of events 1 • Up to 2 years after enrollment.
Blood and lymphatic system disorders Hospitalization for Gram-positive Cocci	6.7% 1/15 • Number of events 1 • Up to 2 years after enrollment.
Blood and lymphatic system disorders Hospitalization for positive line infection	6.7% 1/15 • Number of events 1 • Up to 2 years after enrollment.
Endocrine disorders Pancreatitis	6.7% 1/15 • Number of events 1 • Up to 2 years after enrollment.
Gastrointestinal disorders Hospitalization for abdominal pain (pre-treatment)	6.7% 1/15 • Number of events 1 • Up to 2 years after enrollment.
Infections and infestations Hospitalization for Flu like Symptoms	6.7% 1/15 • Number of events 1 • Up to 2 years after enrollment.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Fryer, MD

Northwestern University

Phone: 312-695-2125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place