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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02598128
Other study ID # ALCT-0000497
Secondary ID
Status Completed
Phase N/A
First received November 3, 2015
Last updated January 24, 2017
Start date November 2015
Est. completion date June 2016

Study information

Verified date January 2017
Source Alcresta Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Protocol ALCT-0000497 consists of three distinct study periods as follows:

1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.

2. In Period B (11 days), subjects will be randomized to either Group A (active investigational then placebo control) or Group B (placebo control then active investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day washout period between Days 1 and 9, subjects will receive Peptamen 1.5.

3. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 4 Years to 45 Years
Eligibility Inclusion Criteria:

1. Confirmed CF diagnosis with 2 clinical features

2. Documented history of EPI

3. Enteral formula use minimum of 4x/week

4. Written informed consent or assent, as applicable

Exclusion Criteria:

1. Uncontrolled diabetes mellitus

2. Signs and symptoms of liver cirrhosis or portal hypertension

3. Lung/liver transplant

4. Active cancer currently receiving cancer treatment

5. Crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease

6. DIOS or fibrosing colonopathy

Study Design


Related Conditions & MeSH terms

  • Exocrine Pancreatic Insufficiency

Intervention

Device:
RELiZORB
Peptamen 1.5 received Period A and Period B (washout only). Impact Peptide 1.5 received Period B (Days 1 and 9 only) and Period C.
Placebo
Sham device

Locations

Country Name City State
United States St. Luke's Cystic Fibrosis Center of Idaho Boise Idaho
United States Rainbow Babies and Children's Hospital Cleveland Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States Riley Hospital for Children at Indiana University Health Indianapolis Indiana
United States Children's Mercy Hospital Kansas City Missouri
United States Children's Hospital of Los Angeles Los Angeles California
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States Monroe Carell Junior Children's Hospital at Vanderbilt Nashville Tennessee
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Maine Medical Center Portland Maine
United States Cardinal Glennon Children's Medical Center Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Alcresta Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Ease of Use of RELiZORB (Per-Protocol Population) Effect of enteral nutrition on select activities of daily living. Patients judged the size of breakfast after overnight enteral tube feeding with the following choices: No breakfast; Small breakfast; Normal breakfast; Big breakfast; Other. Period C: Single assessment on Day 19 or 20
Primary Number of Patients With Adverse Events and Unanticipated Adverse Device Effects 1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE) 27 days
Primary Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population) AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours Day 1 first intervention and Day 9 second intervention.
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