SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

NCT02734810 | Completed Phase 3 Results DMC

• 1 other identifier: AN-EPI3332
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 21

Brief Summary

Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Conditions

Exocrine Pancreatic Insufficiency; Cystic Fibrosis

Keywords

Exocrine Pancreatic Insufficiency; Cystic Fibrosis; Liprotamase; Pancreatic Enzyme Replacement Therapy (PERT)

Outcome Measures

Primary Outcomes (1)

• Safety

  Number of subjects reporting 1 or more adverse events

  1 week

Study Arms (2)

Part A

EXPERIMENTAL

Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age

Drug: Liprotamase Powder for Oral Solution

Part B

EXPERIMENTAL

Liprotamase Powder for Oral Solution in Subjects aged 28 days to \<7 years

Drug: Liprotamase Powder for Oral Solution

Interventions

Liprotamase Powder for Oral Solution DRUG

Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy

Also known as: Liprotamase

Part A; Part B

Eligibility Criteria

• Age: 28 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For Part A: males or females ≥7 years of age
• For Part B: males or females 28 days to \<7 years
• Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
• Low fecal elastase
• Fair-to-good nutritional status

You may not qualify if:

• History or diagnosis of fibrosing colonopathy
• Distal intestinal obstruction syndrome in 6 months prior to screening
• Receiving enteral tube feedings
• Chronic diarrheal illness unrelated to pancreatic insufficiency
• Liver abnormalities, or liver or lung transplant, or significant bowel resection

Sponsors & Collaborators

• Anthera Pharmaceuticals: lead

Study Sites (21)

Investigator Site 139

Little Rock, Arkansas, 72202, United States

Location

Investigator Site

Orange, California, 92868, United States

Location

Investigator Site 114

Aurora, Colorado, 80045, United States

Location

Investigator Site 117

Altamonte Springs, Florida, 32701, United States

Location

Investigator Site 138

Hollywood, Florida, 33021, United States

Location

Investigator Site 130

Miami, Florida, 33136, United States

Location

Investigator Site 110

Atlanta, Georgia, 30342, United States

Location

Investigator Site 109

Glenview, Illinois, 60025, United States

Location

Investigator Site 105

Wichita, Kansas, 67214, United States

Location

Investigator Site 122

Louisville, Kentucky, 40202, United States

Location

Investigator Site 132

Portland, Maine, 04102, United States

Location

Investigator Site 124

Ann Arbor, Michigan, 48109-5212, United States

Location

Investigator Site 135

Las Vegas, Nevada, 89107, United States

Location

Investigator Site 118

Durham, North Carolina, 27710, United States

Location

Investigator Site 101

Oklahoma City, Oklahoma, 73104, United States

Location

Investigator Site 136

Oklahoma City, Oklahoma, 73112, United States

Location

Investigator Site 106

Hershey, Pennsylvania, 17033, United States

Location

Investigator Site 111

Dallas, Texas, 75390-9063, United States

Location

Investigator Site 116

Houston, Texas, 77030, United States

Location

Investigator Site 112

Richmond, Virginia, 23298, United States

Location

Investigator Site 129

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Cystic Fibrosis

Interventions

Solutions; liprotamase lipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Monica Gangal
• Organization: Anthera Pharmaceuticals

info@anthera.com

510-856-5600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 11, 2018
• Results First Posted: May 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)