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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)

Overview

Status
Terminated
Phase
Phase 4
Enrollment
5 participants (actual)
Sponsor
University of Nebraska · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
1 Sept 2003
Primary completion
20 Oct 2008
Completion
20 Oct 2008
First posted
27 Aug 2008 (estimated)
Last update posted
8 Sept 2023
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2003200420052006200720082009
  1. Ph 4

    Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)

    NCT00742157

    1 Sept 2003 to 20 Oct 2008

    Terminated

Registry summary

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

Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN infusions/week.

Interventions

  • Growth HormoneDrug

Arms1

  • Other

    UNMC Group

    Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Documenting the Reduction of TPN Infusion/Week for Participants at 6 Months Compared to Baseline.

    Time frame · 6 months

    Registry description

    Evaluate the number of participants dosed at UNMC who had a reduction in the frequency of TPN infusions/week at 6 months compared to baseline

Secondary outcomes(4)
  1. Change in Hydration Status

    Time frame · 6 months

    Registry description

    Number of participants who were able to maintain euvolemic status at 6 months post treatment

  2. Change in Kidney Function at 6 Months Post Treatment

    Time frame · 6 months

    Registry description

    Number of participants with a significant change in kidney function at 6 months post treatment as compared to baseline.

  3. Change in Liver Function at 6 Months Post Treatment

    Time frame · 6 months

    Registry description

    Number of participants with an improvement in their liver function ALT at 6 months post treatment as compared to baseline.

  4. Change in Physical Functioning Capacity at 6 Months Post Treatment as Compared to Baseline

    Time frame · 6 months

    Registry description

    Number of participants who had a change in their ability to complete all activities of daily living by self at 6 months compared to baseline.

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 outcomeCount of participants· 6 months

Documenting the Reduction of TPN Infusion/Week for Participants at 6 Months Compared to Baseline.

GroupValue (Participants)
UNMC Group5
Secondary and other outcome results(4)
Secondary outcomeNumber· 6 months

Change in Hydration Status

GroupValue (participants)
UNMC Group5
Secondary outcomeCount of participants· 6 months

Change in Kidney Function at 6 Months Post Treatment

GroupValue (Participants)
UNMC Group0
Secondary outcomeCount of participants· 6 months

Change in Liver Function at 6 Months Post Treatment

GroupValue (Participants)
UNMC Group2
Secondary outcomeCount of participants· 6 months

Change in Physical Functioning Capacity at 6 Months Post Treatment as Compared to Baseline

GroupValue (Participants)
UNMC Group0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
UNMC GroupGroup of subjects (n=5) who received treatment0 / 51 / 52 / 5

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 19 Years up to 78 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Be male or female between 19 and 78 years of age, inclusive * Have a diagnosis of SBS and 1 or more of the following characteristics: * Dependent upon TPN and/or IV fluids * Unable to receive TPN because of a documented history of complications associated with the long-term parenteral infusions (e.g. lack of venous access, multiple septic events, progressive liver dysfunction while on TPN, etc) * A documented remnant bowel anatomy that is inconsistent with adequately supporting life without parenteral support (e.g. \< 70 cm of healthy small intestine and a portion of colon, or less than 150 cm in patients with no colon) * A documented history of diarrhea and/or malabsorption that has significantly compromised the patient's nutritional and hydration status (e.g. significant weight loss - 5% over 1 month or 10% over 6 months, or a serum albumin \< 3.5 g/dl, documented nutrient deficiencies, documented episodes of dehydration, etc). * Is able to eat at least some (\>500 calories) of solid food on a regular basis or tolerate at least some (\>500 calories) of an enteral feeding formula * Have stable liver and renal function * For patients with known hypertension and other cardiovascular disorders, be both compensated and stabilized on a regular therapeutic regimen * For women participating in the study, manifest or give assent to 1 of the following criteria to ensure that the patient does not become pregnant during the study: * The patient must be surgically sterile or demonstrably postmenopausal. * Any patient capable of becoming pregnant must have a negative urine pregnancy test and must agree to practice a method of contraception documented to have at least 90% reliability throughout the treatment period. * Have the ability to understand the requirements of the study, to provide written Informed Consent, and to abide by the study restrictions and agree to complete the required assessments in the Follow-up Period Exclusion Criteria: * Be pregnant or lactating * Have a history of mental deficiency or illness that might compromise compliance with the requirements of the study * Have clinically serious neurological dysfunction * Have hypoxemic pulmonary diseases (i.e., resting pAO2 \< 75 torr) * Have unstable ischemic heart disease or uncompensated cardiac failure * Have participated in any study involving an investigations drug within 30 days prior to entry into this trial.

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