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Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study

NCT02750501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-08-15

Study results available
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Summary

Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB use, in patients with cystic fibrosis and exocrine pancreatic insufficiency.

Conditions

Interventions

DEVICE

RELiZORB (immobilized lipase) cartridge

Hydrolyzing fats from enteral formula, ex vivo, with in-line enteral feed RELiZORB (immobilized lipase) cartridge

OTHER

Impact Peptide 1.5

Impact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Alcresta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Madhumalli Sarkar, MD, PhD · Alcresta Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-20
Primary Completion
2017-03-30
Completion
2017-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02750501 on ClinicalTrials.gov