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SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

NCT ID: NCT02734810

Last Updated: 2018-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Exocrine Pancreatic Insufficiency Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A

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

Group Type EXPERIMENTAL

Liprotamase Powder for Oral Solution

Intervention Type DRUG

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

Part B

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

Group Type EXPERIMENTAL

Liprotamase Powder for Oral Solution

Intervention Type DRUG

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

Interventions

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Liprotamase Powder for Oral Solution

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

Intervention Type DRUG

Other Intervention Names

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Liprotamase

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anthera Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigator Site 139

Little Rock, Arkansas, United States

Site Status

Investigator Site

Orange, California, United States

Site Status

Investigator Site 114

Aurora, Colorado, United States

Site Status

Investigator Site 117

Altamonte Springs, Florida, United States

Site Status

Investigator Site 138

Hollywood, Florida, United States

Site Status

Investigator Site 130

Miami, Florida, United States

Site Status

Investigator Site 110

Atlanta, Georgia, United States

Site Status

Investigator Site 109

Glenview, Illinois, United States

Site Status

Investigator Site 105

Wichita, Kansas, United States

Site Status

Investigator Site 122

Louisville, Kentucky, United States

Site Status

Investigator Site 132

Portland, Maine, United States

Site Status

Investigator Site 124

Ann Arbor, Michigan, United States

Site Status

Investigator Site 135

Las Vegas, Nevada, United States

Site Status

Investigator Site 118

Durham, North Carolina, United States

Site Status

Investigator Site 101

Oklahoma City, Oklahoma, United States

Site Status

Investigator Site 136

Oklahoma City, Oklahoma, United States

Site Status

Investigator Site 106

Hershey, Pennsylvania, United States

Site Status

Investigator Site 111

Dallas, Texas, United States

Site Status

Investigator Site 116

Houston, Texas, United States

Site Status

Investigator Site 112

Richmond, Virginia, United States

Site Status

Investigator Site 129

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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AN-EPI3332

Identifier Type: -

Identifier Source: org_study_id

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