Trial Outcomes & Findings for Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS) (NCT NCT00742157)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

6 months

Results posted on

2023-09-08

Participant Flow

Patients (n=5) were recruited between 9/2003 and 4/2008 in a gastroenterology clinic in the university hospital ( single site)

Participant milestones

Participant milestones
Measure	Single Arm Protocol An Open-label Evaluation of the Long-term Efficacy and Safety of a Standardized Regimen of Growth Hormone, Glutamine and a Modified Diet in the Treatment of Patients with Short Bowel Syndrome
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UNMC Group n=5 Participants Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose). Growth Hormone: dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.6 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 5/5 participants dosed at UNMC had a reduction in the frequency of TPN infusions/week at 6 months compared to baseline.

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

Outcome measures

Outcome measures
Measure	UNMC Group n=5 Participants Participants dosed at UNMC with 0.05mg/kg/day in diluent for injection, once a day for 23-54 days
Documenting the Reduction of TPN Infusion/Week for Participants at 6 Months Compared to Baseline.	5 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	UNMC Group n=5 Participants Participants dosed at UNMC with 0.05mg/kg/day in diluent for injection, once a day for 23-54 days
Change in Hydration Status	5 participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	UNMC Group n=5 Participants Participants dosed at UNMC with 0.05mg/kg/day in diluent for injection, once a day for 23-54 days
Change in Kidney Function at 6 Months Post Treatment	0 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	UNMC Group n=5 Participants Participants dosed at UNMC with 0.05mg/kg/day in diluent for injection, once a day for 23-54 days
Change in Liver Function at 6 Months Post Treatment	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	UNMC Group n=5 Participants Participants dosed at UNMC with 0.05mg/kg/day in diluent for injection, once a day for 23-54 days
Change in Physical Functioning Capacity at 6 Months Post Treatment as Compared to Baseline	0 Participants

Adverse Events

UNMC Group

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	UNMC Group n=5 participants at risk Group of subjects (n=5) who received treatment
Infections and infestations bacteremia	20.0% 1/5 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	UNMC Group n=5 participants at risk Group of subjects (n=5) who received treatment
Cardiac disorders edema	20.0% 1/5 • Number of events 1 • 6 months
Endocrine disorders hyperglycemia	20.0% 1/5 • Number of events 1 • 6 months

Additional Information

Fedja Rochling, MD

University of Nebraska Medical Center

Phone: 402-559-3652

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place