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

NCT00742157 | Terminated Phase 4 Results

• 1 other identifier: 0061-03-FB
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Short Bowel Syndrome

Keywords

Growth Hormone; TPN; Total Parenteral Nutrition; Glutamine; Short Bowel Syndrome; Increase in absorption of small bowel.

Outcome Measures

Primary Outcomes (1)

• Documenting the Reduction of TPN Infusion/Week for Participants 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

  6 months

Secondary Outcomes (4)

• Change in Hydration Status

  6 months

• Change in Kidney Function at 6 Months Post Treatment

  6 months

• Change in Liver Function at 6 Months Post Treatment

  6 months

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

  6 months

Study Arms (1)

UNMC Group

OTHER

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

Drug: Growth Hormone

Interventions

Growth Hormone DRUG

dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.

Also known as: Humatrope = Somatropin (rDNA origin) for injection

UNMC Group

Eligibility Criteria

• Age: 19 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome; Hyperphagia

Interventions

Growth Hormone; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins

Results Point of Contact

• Title: Fedja Rochling, MD
• Organization: University of Nebraska Medical Center

frochling@unmc.edu

402-559-3652

Study Officials

• Fedja Rochling, MB, ChB

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: September 1, 2003
• Primary Completion: October 20, 2008
• Study Completion: October 20, 2008
• Last Updated: September 8, 2023
• Results First Posted: July 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)