N/A
N=34
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Exocrine Pancreatic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02598128 ↗Enrolled (actual)
34
Serious AEs
1.0%
Results posted
Jan 2017
Primary outcome: Primary: Number of Patients With Adverse Events and Unanticipated Adverse Device Effects — 4; 6; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RELiZORB (Device); Placebo (Device)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Alcresta Therapeutics, Inc.
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events and Unanticipated Adverse Device Effects |
4; 6; 1; 2; 2; 6 | — |
| PRIMARY Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population) |
536.98; 192.18 | <0.001 sig |
Summary
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis. Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.
Eligibility Criteria
Inclusion Criteria
- Confirmed CF diagnosis with 2 clinical features
- Documented history of EPI
- Enteral formula use minimum of 4x/week
- Written informed consent or assent, as applicable
Exclusion Criteria
- Uncontrolled diabetes mellitus
- Signs and symptoms of liver cirrhosis or portal hypertension
- Lung/liver transplant
- Active cancer currently receiving cancer treatment
- Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease
- DIOS or fibrosing colonopathy
Data sourced from ClinicalTrials.gov (NCT02598128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.