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rHGH and Intestinal Permeability in Intestinal Failure (rHGH)

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ClinicalTrials.gov Identifier: NCT01380366
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : March 31, 2014
Last Update Posted : February 8, 2016
Sponsor:
Collaborators:
Northwestern Memorial Hospital
EMD Serono
Information provided by (Responsible Party):
Jonathan Fryer, Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Short Bowel Syndrome
Interventions Drug: Somatropin
Procedure: Seven Day Food Diary
Procedure: Blood Tests (standard of care)
Other: Fasting
Other: Sugar Permeability Test
Other: Urine Collection
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zorptive Subjects
Hide Arm/Group Description Patients consent to rHGH and Intestinal Permeability in Intestinal Failure Study
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Patients Consented to be Given rHGH
Hide Arm/Group Description Patients given growth hormone (rHGH) for their short bowel syndrome.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Patients Consented to be Given rHGH
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  86.7%
>=65 years
2
  13.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
50.1  (15.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
10
  66.7%
Male
5
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).
Hide Description 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.
Time Frame (Visit 1) Baseline to (Visit 2) 28-31 days after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Experiencing Decrease in Concentration of Sucralose
Hide Arm/Group Description:
A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
7
2.Secondary Outcome
Title To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.
Hide Description 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.
Time Frame (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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patient Decreased Liver Injury
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
7
Time Frame Up to 2 years after enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Consented to be Given rHGH
Hide Arm/Group Description Patients given growth hormone (rHGH) for their short bowel syndrome.
All-Cause Mortality
Patients Consented to be Given rHGH
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Consented to be Given rHGH
Affected / at Risk (%) # Events
Total   6/15 (40.00%)    
Blood and lymphatic system disorders   
Hospitalization for Escherichia coli Infection  1/15 (6.67%)  1
Hospitalization for Gram-positive Cocci  1/15 (6.67%)  1
Hospitalization for positive line infection  1/15 (6.67%)  1
Endocrine disorders   
Pancreatitis  1/15 (6.67%)  1
Gastrointestinal disorders   
Hospitalization for abdominal pain (pre-treatment)  1/15 (6.67%)  1
Infections and infestations   
Hospitalization for Flu like Symptoms  1/15 (6.67%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients Consented to be Given rHGH
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Number of participants is low. Time period of evaluation may not have been adequate for evaluating the impact on liver injury. Parameters used to evaluate the impact of gut permeability changes on hepatic inflammation and injury were very limited.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jonathan Fryer, MD
Organization: Northwestern University
Phone: 312-695-2125
EMail: jfryer@nmh.org
Layout table for additonal information
Responsible Party: Jonathan Fryer, Northwestern University
ClinicalTrials.gov Identifier: NCT01380366     History of Changes
Other Study ID Numbers: STU00012123 0208-007
CNV0050754 ( Other Identifier: Internal Tracking Sponsor Contract ID )
First Submitted: June 22, 2011
First Posted: June 27, 2011
Results First Submitted: February 14, 2014
Results First Posted: March 31, 2014
Last Update Posted: February 8, 2016