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RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

NCT ID: NCT03051490

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2018-06-30

Brief Summary

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Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will be comparative efficacy measured as the change from baseline in the coefficient of fat absorption (CFA) 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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

unblinded to treatment randomization; blinded to primary efficacy variable

Study Groups

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Liprotamase

Individually-optimized dose to be administered orally

Group Type EXPERIMENTAL

Liprotamase

Intervention Type DRUG

oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement

porcine PERT

Individually-optimized dose to be administered orally

Group Type ACTIVE_COMPARATOR

porcine PERT

Intervention Type DRUG

oral, enterically-coated, pig-derived, pancreatic enzyme replacement

Interventions

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Liprotamase

oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement

Intervention Type DRUG

porcine PERT

oral, enterically-coated, pig-derived, pancreatic enzyme replacement

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride
* Fecal elastase \<100 mcg/g stool
* Good disease control with porcine PERT prior to enrollment
* 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
* Forced expiratory volume in 1 second (FEV1) \<30%
Minimum Eligible Age

7 Years

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

Principal Investigators

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Monica Gangal

Role: STUDY_DIRECTOR

Anthera Pharmaceuticals

Locations

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Investigator Site 139

Little Rock, Arkansas, United States

Site Status

Investigator Site #123

Long Beach, California, United States

Site Status

Investigator Site 107

Los Angeles, California, United States

Site Status

Investigator Site 143

Orange, California, United States

Site Status

Investigator Site 150

Denver, Colorado, United States

Site Status

Investigator Site 147

Wilmington, Delaware, United States

Site Status

Investigator Site 117

Altamonte Springs, Florida, United States

Site Status

Investigator Site 102

Jacksonville, Florida, United States

Site Status

Investigator Site 130

Miami, Florida, United States

Site Status

Investigator Site 151

West Palm Beach, 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 148

Iowa City, Iowa, 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 140

Kalamazoo, Michigan, United States

Site Status

Investigator Site 134

Jackson, Mississippi, 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 #103

Cleveland, Ohio, United States

Site Status

Site Investigator #113

Toledo, Ohio, 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 302

Törökbálint, Pest County, Hungary

Site Status

Investigator Site 304

Mosdós, Somogy County, Hungary

Site Status

Investigator Site 306

Budapest, , Hungary

Site Status

Investigator Site 307

Budapest, , Hungary

Site Status

Investigator Site 601

Jerusalem, , Israel

Site Status

Investigator Site 901

Kaunas, , Lithuania

Site Status

Investigator Site #902

Vilnius, , Lithuania

Site Status

Investigator Site 203

Karpacz, , Poland

Site Status

Site 206

Lodz, , Poland

Site Status

Investigator Site 201

Lublin, , Poland

Site Status

Investigator Site 205

Lublin, , Poland

Site Status

Investigator Site 202

Rabka-Zdrój, , Poland

Site Status

Investigator Site 209

Rzeszów, , Poland

Site Status

Investigator 204

Sopot, , Poland

Site Status

Investigator Site 210

Łomianki, , Poland

Site Status

Investigator Site 405

El Palmar, Murcia, Spain

Site Status

Investigator Site 401

Madrid, , Spain

Site Status

Investigator Site 403

Madrid, , Spain

Site Status

Investigator Site 402

Málaga, , Spain

Site Status

Investigator Site 404

Valencia, , Spain

Site Status

Investigatior Site 701

Southampton, Hampshire, United Kingdom

Site Status

Investigator Site 702

Exeter, , United Kingdom

Site Status

Countries

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United States Hungary Israel Lithuania Poland Spain United Kingdom

Other Identifiers

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AN-EPI3333

Identifier Type: -

Identifier Source: org_study_id

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