CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
RELiZORB (immobilized lipase) cartridge +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02750501
NCT02750501N/ACompleted
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Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding

Alcresta Therapeutics, Inc.·interventional·Posted Apr 25, 2016·Updated Aug 15, 2018

In Brief

A clinical study evaluating RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5 for Cystic Fibrosis. Completed, enrolled 49 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
CollaboratorsCystic Fibrosis Foundation

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 25, 2016
Enrollment StartJul 20, 2016
Primary CompletionMar 30, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.2 years ago

Interventions

RELiZORB (immobilized lipase) cartridgedevice

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

Impact Peptide 1.5other

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