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Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
NA trial testing RELiZORB (immobilized lipase) cartridge in Cystic Fibrosis in 49 participants. Completed in 30 March 2017.
| Lead sponsor | Alcresta Therapeutics, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 20 July 2016 |
| Primary completion | 30 March 2017 |
| Estimated completion | 30 March 2017 |
| Sites | 10 locations across United States |
Alcresta Therapeutics, Inc.
4 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Cartridge With Standard Enteral Formula | 5.01 | ± 0.40 |
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.
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Treatment Period (Day 0 - Day 90) | 10 |
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Treatment Period (Day 0 - Day 90) | 2 |
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Treatment Period (Day 0 - Day 90) | 8 |
Changes in plasma concentration total DHA+EPA from baseline (Day 0 to Day 90).
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Treatment Period (Day 0 - Day 90) | 93.73 | 69.50 – 117.96 |
Changes over time in erythrocyte composition (%) for total DHA in ITT population (n=39)
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Treatment Period (Day 0 - Day 90) | 3.28 | 2.74 – 3.82 |
Changes over time in erythrocyte composition (%) for EPA in ITT population
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Treatment Period (Day 0 - Day 90) | 1.73 | 1.32 – 2.14 |
Change from baseline to Day 90 in n6/n3 ratio in erythrocytes
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Treatment Period (Day 0 - Day 90) | -2.51 | -2.94 – -2.09 |
Change over time in n6/n3 ratio in plasma in the ITT population
| Group | Value | 95% CI |
|---|---|---|
| RELiZORB Treatment Period (Day 0 - Day 90) | -6.29 | -7.85 – -4.73 |
GI symptoms recorded in GI diaries by subject and/or caregiver.
| Group | Value | 95% CI |
|---|---|---|
| Safety Population | 23 |
| Group | Value | 95% CI |
|---|---|---|
| Safety Population | 12 |
Time frame: Adverse event data collected and reported for 14 days during the Observation and Run-in periods. Adverse event data collected and reported for 120 days for the RELiZORB period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Observation and Run-in Per… | RELiZORB Treatment Period … |
|---|---|---|---|
| Infectious colitis | Infections and infestations | — | — |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | — | — |
| Reaction | System | Observation and Run-in Per… | RELiZORB Treatment Period … |
|---|---|---|---|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Pulmonary function decreased | Investigations | — | — |
| Pyrexia | General disorders | — | — |
| Ear infection | Infections and infestations | — | — |
| Forced expiratory volume decreased | Investigations | — | — |
| Vitamin D decrease | Investigations | — | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Infectious colitis, Infective pulmonary exacerbation of cystic fibrosis.
Data from ClinicalTrials.gov NCT02750501 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing