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SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis

NCT ID: NCT02279498

Last Updated: 2018-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-20

Brief Summary

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Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.

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Detailed Description

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Porcine derived enzymes are used for pancreatic enzyme replacement therapy in patients with cystic fibrosis (CF). Liprotamase is a biotechnology-derived enzyme replacement without enteric coating. This is an open-label, assessor blind, parallel group, multicenter, international trial to evaluate the noninferiority of liprotamase and pancrelipase in CF patients aged ≥7 years with pancreatic insufficiency. Subjects were randomized to liprotamase or pancrelipase, dose-matched to pre-study lipase doses. The lower bound of the 95% confidence interval (CI) for noninferiority was -15% for treatment difference in change from baseline coefficient of fat absorption (CFA).

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

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 (pig) PERT

Individually-optimized dose to be administered orally

Group Type ACTIVE_COMPARATOR

porcine (pig) PERT

Intervention Type DRUG

oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source

Interventions

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Liprotamase

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

Intervention Type DRUG

porcine (pig) PERT

oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source

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
* Minimum Coefficient of Fat (CFA) at screening while on stable PERT therapy
* 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 123

Long Beach, California, United States

Site Status

Investigator Site 107

Los Angeles, California, United States

Site Status

Investigator Site 114

Aurora, Colorado, United States

Site Status

Investigator Site 120

Gainesville, 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 117

Orlando, Florida, United States

Site Status

Investigator Site 110

Atlanta, Georgia, United States

Site Status

Investigator Site 127

Chicago, Illinois, United States

Site Status

Investigator Site 109

Glenview, Illinois, United States

Site Status

Investigator Site 104

Indianapolis, Indiana, United States

Site Status

Investigator Site 105

Wichita, Kansas, United States

Site Status

Investigator Site 128

Lexington, Kentucky, 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 126

East Lansing, 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 103

Cleveland, Ohio, United States

Site Status

Investigator Site 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 119

Portland, Oregon, United States

Site Status

Investigator Site 106

Hershey, Pennsylvania, United States

Site Status

Investigator Site 115

Pittsburgh, Pennsylvania, United States

Site Status

Investigator Site 111

Dallas, Texas, United States

Site Status

Investigator Site 125

Fort Worth, Texas, United States

Site Status

Investigator Site 116

Houston, Texas, United States

Site Status

Investigator Site 121

Burlington, Vermont, United States

Site Status

Investigator Site 112

Richmond, Virginia, United States

Site Status

Investigator Site 129

Morgantown, West Virginia, United States

Site Status

Investigator Site 133

Edmonton, Alberta, Canada

Site Status

Investigator Site 501

Brno, , Czechia

Site Status

Investigator Site 502

Pilsen, , Czechia

Site Status

Investigator Site 305

Szeged, Csongrád megye, Hungary

Site Status

Investigator Site 303

Debrecen, Hajdú-Bihar, Hungary

Site Status

Investigator Site 302

Törökbálint, Pest County, Hungary

Site Status

Investigator Site 304

Mosdós, Somogy County, Hungary

Site Status

Investigator Site 301

Ajka, Veszprém megye, Hungary

Site Status

Investigator Site 601

Jerusalem, , Israel

Site Status

Investigator Site 208

Bialystok, , Poland

Site Status

Investigator Site 203

Karpacz, , Poland

Site Status

Investigator 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 Site 204

Sopot, , Poland

Site Status

Investigator Site 207

Warsaw, , Poland

Site Status

Investigator Site 403

Madrid, , Spain

Site Status

Investigator Site 401

Madrid, , Spain

Site Status

Investigator Site 402

Málaga, , Spain

Site Status

Investigator Site 404

Valencia, , Spain

Site Status

Countries

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United States Canada Czechia Hungary Israel Poland Spain

References

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Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.

Reference Type DERIVED
PMID: 32761612 (View on PubMed)

Other Identifiers

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AN-EPI3331

Identifier Type: -

Identifier Source: org_study_id

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