EASY: Extended Access to Sollpura Over Years

NCT02823964 | Completed Phase 4 Results DMC

• 1 other identifier: AN-EPI3334
• Study Type: interventional
• Target: 25
• Locations: 6 countries
• Sites: 15

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.

Conditions

Exocrine Pancreatic Insufficiency; Cystic Fibrosis

Keywords

exocrine pancreatic insufficiency; cystic fibrosis; pancreatic enzyme replacement therapy

Outcome Measures

Primary Outcomes (1)

• Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities

  Descriptive analysis

  12 months

Study Arms (1)

Liprotamase

EXPERIMENTAL

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

Drug: Liprotamase

Interventions

Liprotamase DRUG

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

Also known as: Sollpura

Liprotamase

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)

You may not qualify if:

• Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
• Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.

Sponsors & Collaborators

• Anthera Pharmaceuticals: lead

Study Sites (15)

Investigator Site 114

Aurora, Colorado, 80045, United States

Location

Investigator Site 134

Jackson, Mississippi, 39216, United States

Location

Investigator Site 121

Burlington, Vermont, 05401, United States

Location

Investigator Site 501

Brno, 625 00, Czechia

Location

Investigator Site 303

Debrecen, Hajdú-Bihar, 4031, Hungary

Location

Investigator Site 302

Törökbálint, Pest County, 2045, Hungary

Location

Investigator Site 304

Mosdós, Somogy County, 7257, Hungary

Location

Investigator Site 301

Ajka, Veszprém megye, 8400, Hungary

Location

Investigator Site 601

Jerusalem, 9124001, Israel

Location

Investigator Site 203

Karpacz, 58-540, Poland

Location

Investigator Site 206

Lodz, 90-329, Poland

Location

Investigator Site 205

Lublin, 20-362, Poland

Location

Investigator Site 202

Rabka-Zdrój, 34-700, Poland

Location

Investigator Site 209

Rzeszów, 35-612, Poland

Location

Investigator Site 401

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Cystic Fibrosis

Interventions

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

Results Point of Contact

• Title: Nicole Ramza
• 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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 17, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5); ES (1); HU (4); CZ (1); IL (1); US (3)