Documenting the Reduction of TPN Infusion/Week for Participants at 6 Months Compared to Baseline.
| Group | Value (Participants) |
|---|---|
| UNMC Group | 5 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Lack of Enrollment
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
NCT007421571 Sept 2003 to 20 Oct 2008
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.
Other
UNMC Group
Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).
Outcomes the sponsor listed as primary.
Documenting the Reduction of TPN Infusion/Week for Participants at 6 Months Compared to Baseline.
Time frame · 6 months
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
Change in Hydration Status
Time frame · 6 months
Number of participants who were able to maintain euvolemic status at 6 months post treatment
Change in Kidney Function at 6 Months Post Treatment
Time frame · 6 months
Number of participants with a significant change in kidney function at 6 months post treatment as compared to baseline.
Change in Liver Function at 6 Months Post Treatment
Time frame · 6 months
Number of participants with an improvement in their liver function ALT at 6 months post treatment as compared to baseline.
Change in Physical Functioning Capacity at 6 Months Post Treatment as Compared to Baseline
Time frame · 6 months
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| UNMC Group | 5 |
| Group | Value (participants) |
|---|---|
| UNMC Group | 5 |
| Group | Value (Participants) |
|---|---|
| UNMC Group | 0 |
| Group | Value (Participants) |
|---|---|
| UNMC Group | 2 |
| Group | Value (Participants) |
|---|---|
| UNMC Group | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| UNMC GroupGroup of subjects (n=5) who received treatment | 0 / 5 | 1 / 5 | 2 / 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
Studies that cite this trial.
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Who could join, as posted.
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