A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Launched by BOSTON CHILDREN'S HOSPITAL · Nov 23, 2022

Keywords

ClinConnect Summary

Short bowel syndrome (SBS) is often due to the loss of large amounts of small intestine that compromises digestive absorption. The treatments include (1) a high-calorie diet that includes vitamins, minerals, carbohydrates, proteins and fats; (2) injections of vitamins and minerals; (3) administration of drugs to slow the normal movement of the intestine or to increase the surface area of the intestinal lining; and (4) feeding through the vein (i.e., parenteral nutrition or PN). Many patients cannot wean from PN due to reduced intestinal length or function. Patients on long-term PN frequentl...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is currently enrolled in the ongoing RELiZORB study titled "A 90 day, Phase 3, Open Labeled Exploratory Study of RELiZORB to Evaluate Safety, Tolerability, and Nutrient Absorption in Children with Short Bowel Syndrome who are Dependent on Parenteral Nutrition"
• • 2. The parent or legal guardian of the patient is able to read, understand, and is willing to provide informed consent (and assent, if applicable).
• • 3. The patient (if assent is applicable) or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the patient to all clinic visits and complete all study-related procedures (as determined by the investigator).
• • 4. A parent or legal guardian is willing to provide written authorization for the use and disclosure of protected health information.
• Exclusion Criteria:
• • 1. Active clinically-significant pancreatic or biliary disease, as determined by the investigator.
• • 2. Change in patient formula such that the new formula is not compatible with the RELiZORB cartridge (example, insoluble fiber-containing formulas)
• • 3. Determined by the investigator to be unsuitable for participation for any reason.