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Trial · Interventional

CompletedPhase 4Results postedRegistry data

rHGH and Intestinal Permeability in Intestinal Failure

Short name rHGH

NCTNCT01380366 (opens ClinicalTrials.gov in a new tab)Other idSTU00012123 0208-007Other idCNV0050754
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
15 participants (actual)
Sponsor
Northwestern University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2006
Primary completion
Feb 2011
Completion
Feb 2015
First posted
27 Jun 2011 (estimated)
Last update posted
8 Feb 2016 (estimated)
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620082010201220142016
  1. Ph 4

    rHGH

    NCT01380366

    Oct 2006 to Feb 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Patients who are being asked to participate in this study have a short small bowel and will be prescribed to take the medication: Zorbtive® ("Zorbtive/Somatropin/(rHGH)"). Zorbtive® is an FDA approved recombinant human growth hormone (rHGH). The investigators want to see if taking this medication improves small bowel function by helping it to take in food, nutrients, vitamins and minerals. The investigators also believe that if the small bowel is absorbing food and nutrients better, liver function will improve as well. Therefore, liver function will also be monitored during the course of the study by performing blood tests.

Interventions

  • SomatropinDrug
  • Seven Day Food DiaryProcedure
  • Blood Tests (standard of care)Procedure
  • FastingOther
  • Sugar Permeability TestOther
  • Urine CollectionOther

Arms1

  • Other

    Patients consent to rHGH study

    Patients consent to be given growth hormone (rHGH) for their short bowel syndrome.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).

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

    Registry 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.

Secondary outcomes(1)

  1. To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.

    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

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).

GroupValue (participants)
Patients Experiencing Decrease in Concentration of Sucralose7
Secondary and other outcome results(1)
Secondary outcomeNumber· (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

To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.

GroupValue (participants)
Patient Decreased Liver Injury7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Patients Consented to be Given rHGHPatients given growth hormone (rHGH) for their short bowel syndrome.–6 / 150 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subjects must be between the ages of 18 and 80 * Subjects can be male or female * Subjects must have short bowel syndrome with \<200cm of functional small bowel or have severe small bowel dysfunction mandating regular (at least two times per week) administration of total parenteral nutrition (TPN) and/or IV fluids. * Subjects must have been dependent on TPN or IV fluids for 1 year, or are expected to be dependent on TPN or IV fluids for at least 1 yr. * Subjects must be patients being seen in the Northwestern intestinal failure clinic * Subjects must be willing to spend one night in the Clinical Research Center * Subjects must be able to read, understand and be able to sign the study specific informed consent Exclusion Criteria: * Subjects must be greater than or equal to 18 years of age, but less than or equal to 80 years of age * Infections requiring antibiotic therapy within one week of starting the study * Subjects must not have evidence of an ongoing malignancy for two years * Subjects must not have history of antibiotic use within one week of initiating the study. Subjects may enroll in the study as long as Visit 1 is at least one week from the last dose of antibiotics. * Subjects that have evidence of acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure * Subjects with known liver disease, positive hepatitis B virus (HBV), or hepatitis C virus (HCV) serology * Subjects unwilling to abstain from alcohol 7 days prior to and during the 28 days of Zorbtive® therapy, until completion of Visit 2 * Subjects with a known sensitivity to Benzyl Alcohol * Subjects with a known sensitivity to growth hormone * Female subjects that are unable or unwilling to use effective, acceptable birth control methods throughout the study and for up to 6 months after completing treatment with Zorbtive therapy * Female subject with a positive pregnancy test

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