NCT02598128

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

November 3, 2015

Results QC Date

November 14, 2016

Last Update Submit

January 24, 2017

Conditions

Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

Other Outcomes (1)

  • Ease of Use of RELiZORB (Per-Protocol Population)

    Period C: Single assessment on Day 19 or 20

Study Arms (2)

RELiZORB

EXPERIMENTAL

Treatment (RELiZORB)

Device: RELiZORB

Control

PLACEBO COMPARATOR

Placebo control

Device: Placebo

Interventions

RELiZORBDEVICE

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.

Also known as: Peptamen 1.5, Impact Peptide 1.5
RELiZORB
PlaceboDEVICE

Sham device

Control

Eligibility Criteria

Age4 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

St. Luke's Cystic Fibrosis Center of Idaho

Boise, Idaho, 83712, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Monroe Carell Junior Children's Hospital at Vanderbilt

Nashville, Tennessee, 37332, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Freedman S, Orenstein D, Black P, Brown P, McCoy K, Stevens J, Grujic D, Clayton R. Increased Fat Absorption From Enteral Formula Through an In-line Digestive Cartridge in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):97-101. doi: 10.1097/MPG.0000000000001617.

    PMID: 28471913DERIVED

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Results Point of Contact

Title
Russell G. Clayton, D.O., Chief Medical Officer
Organization
Alcresta Therapeutics, Inc.
rclayton@alcresta.com
215.813.5100

Study Officials

  • Russell G. Clayton, Sr., DO

    Chief Medical Officer, Alcresta Therapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 5, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 25, 2017

Results First Posted

January 20, 2017

Record last verified: 2017-01

Locations

US(11)