Cystic FibrosisASSURENCT02750501
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
A study testing RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5 in people with Cystic Fibrosis, run by Alcresta Therapeutics, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 Jul 2016to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of cystic fibrosis
- Documented history of exocrine pancreatic insufficiency
- Enteral formula use a minimum of 4x/week, using PERT, consuming an unrestricted fat diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5
- Written informed consent or assent.
Who cannot join
- Uncontrolled diabetes mellitus
- Signs and symptoms of liver cirrhosis or portal hypertension
- Lung or liver transplant
- Active cancer currently receiving cancer treatment
- Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
St. Luke's CF Center of Idaho
Boise, Idaho, 83712
Nationwide Children's Hospital
Columbus, Ohio, 43205
Dayton Children's Hospital
Dayton, Ohio, 45404-1815
Helen DeVos Children's Hospital CF Care Center
Grand Rapids, Michigan, 49503
Joe DiMaggio Children's Hospital / Memorial Healthcare System
Hollywood, Florida, 33021
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Maine Medical Center
Portland, Maine, 04102
Cardinal Glennon Children's Hospital / Saint Louis University
St Louis, Missouri, 63104
About this study
Official title: Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding
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.
Read the detailed description
Study Entry (Day -14): Baseline blood samples collected for plasma and erythrocyte concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA). Baseline characteristics collected included BMI and cystic fibrosis related diabetes.
Observation Period (Day -14 to Day -8): Subjects followed their usual enteral nutrition regimen with pancreatic enzyme replacement therapy (PERT).
Run-in Period (Day -7 to Day -1): Subjects used Peptamen 1.5 enteral formula at their normal volume of administration from 500 mL to 1,000 mL per feeding with usual PERT regimen.
Treatment Period (Day 0 to Day 90): Subjects used Impact Peptide 1.5 up to a maximum volume of 1,000 mL per feeding with RELiZORB for the 90 day treatment period. Blood screening measurements were repeated at start of treatment period (Day 0), Day 30, Day 60 and Day 90. PERT use with enteral feedings was prohibited. Safety and tolerability were assessed with GI symptom diaries and systematic assessments of adverse events and unanticipated adverse device effects.
- Conditions
- Cystic Fibrosis
- Being tested
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Keywords
- CF, EPI, diabetes, PERT, LCPUFA, DHA, EPA, Omega-3 index
- Medical subject headings
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELiZORB (immobilized lipase) cartridgeDevice
Hydrolyzing fats from enteral formula, ex vivo, with in-line enteral feed RELiZORB (immobilized lipase) cartridge
Impact Peptide 1.5Other
Also called Enteral Formula
Impact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5 | Other | RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5 with enteral feedings ranging from 500 mL to 1,000 mL per feeding for a period of 90 days. Receives: Device: RELiZORB (immobilized lipase) cartridge; Other: Impact Peptide 1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)
Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index
Measured: Day 0 to Day 90
Secondary outcomes (6)
Unanticipated Adverse Device Effects (UADE)
A UADE is analogous to a serious adverse event (SAE), defined as an AE, occurring at any exposure to the therapeutic agent, that results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant disability or incapacity or a congenital anomaly/birth defect.
Measured: RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up.
Changes in Plasma Concentration Total DHA+EPA
Changes in plasma concentration total DHA+EPA from baseline (Day 0 to Day 90).
Measured: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Erythrocyte Composition (%) of DHA
Changes over time in erythrocyte composition (%) for total DHA in ITT population (n=39)
Measured: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Erythrocyte Composition (%) of EPA
Changes over time in erythrocyte composition (%) for EPA in ITT population
Measured: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids
Change from baseline to Day 90 in n6/n3 ratio in erythrocytes
Measured: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Plasma Composition (%) Ratio of n6/n3 Fatty Acids.
Change over time in n6/n3 ratio in plasma in the ITT population
Measured: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start20 Jul 2016
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcresta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Madhumalli Sarkar, MD, PhD, Study director, Alcresta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750501
- Sponsor's protocol ID
- Protocol 0000498-02
- Acronym
- ASSURE
- Status last verified
- Jun 2018
- First submitted
- 20 Apr 2016
- Last updated
- 15 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding
- ClinicalTrials.gov ID
- NCT02750501
- Acronym / sponsor ID
- ASSURE / Protocol 0000498-02
- Conditions
- Cystic Fibrosis
- Keywords
- CF, EPI, diabetes, PERT, LCPUFA, DHA, EPA, Omega-3 index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Alcresta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 18 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Entry (Day -14): Baseline blood samples collected for plasma and erythrocyte concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA). Baseline characteristics collected included BMI and cystic fibrosis related diabetes.
Observation Period (Day -14 to Day -8): Subjects followed their usual enteral nutrition regimen with pancreatic enzyme replacement therapy (PERT).
Run-in Period (Day -7 to Day -1): Subjects used Peptamen 1.5 enteral formula at their normal volume of administration from 500 mL to 1,000 mL per feeding with usual PERT regimen.
Treatment Period (Day 0 to Day 90): Subjects used Impact Peptide 1.5 up to a maximum volume of 1,000 mL per feeding with RELiZORB for the 90 day treatment period. Blood screening measurements were repeated at start of treatment period (Day 0), Day 30, Day 60 and Day 90. PERT use with enteral feedings was prohibited. Safety and tolerability were assessed with GI symptom diaries and systematic assessments of adverse events and unanticipated adverse device effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5 | Other | Device: RELiZORB (immobilized lipase) cartridge, Other: Impact Peptide 1.5RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5 with enteral feedings ranging from 500 mL to 1,000 mL per feeding for a period of 90 days. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of cystic fibrosis
- Documented history of exocrine pancreatic insufficiency
- Enteral formula use a minimum of 4x/week, using PERT, consuming an unrestricted fat diet, and willing to use Peptamen 1.5 and Impact Peptide 1.5
- Written informed consent or assent.
Key exclusion criteria (5 listed)
- Uncontrolled diabetes mellitus
- Signs and symptoms of liver cirrhosis or portal hypertension
- Lung or liver transplant
- Active cancer currently receiving cancer treatment
- Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELiZORB (immobilized lipase) cartridgeHydrolyzing fats from enteral formula, ex vivo, with in-line enteral feed RELiZORB (immobilized lipase) cartridge | Device | Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5 |
| Impact Peptide 1.5Also: Enteral FormulaImpact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding | Other | Single Arm: Open label RELiZORB Cartridge & Impact Peptide 1.5 |
Primary outcome
Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)
Time frame: Day 0 to Day 90
Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index
6 secondary outcomes
Unanticipated Adverse Device Effects (UADE)
Time frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up.
Changes in Plasma Concentration Total DHA+EPA
Time frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Erythrocyte Composition (%) of DHA
Time frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Erythrocyte Composition (%) of EPA
Time frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids
Time frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Plasma Composition (%) Ratio of n6/n3 Fatty Acids.
Time frame: RELiZORB Treatment Period (Day 0-Day 90): 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhumalli Sarkar, MD, PhD study director
Alcresta Therapeutics, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELiZORB (immobilized lipase) cartridge and Impact Peptide 1.5 in people with Cystic Fibrosis, run by Alcresta Therapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA) (time frame: Day 0 to Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.