EASY: Extended Access to Sollpura Over Years

April 19, 2018 updated by: Anthera Pharmaceuticals

An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 625 00
        • Investigator Site 501
  • Hungary
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4031
        • Investigator Site 303
    • Pest County
      • Torokbalint, Pest County, Hungary, 2045
        • Investigator Site 302
    • Somogy County
      • Mosdos, Somogy County, Hungary, 7257
        • Investigator Site 304
    • Veszprem County
      • Ajka, Veszprem County, Hungary, 8400
        • Investigator site 301
  • Israel
      • Jerusalem, Israel, 9124001
        • Investigator Site 601
  • Poland
      • Karpacz, Poland, 58-540
        • Investigator site 203
      • Lodz, Poland, 90-329
        • Investigator site 206
      • Lublin, Poland, 20-362
        • Investigator site 205
      • Rabka-Zdroj, Poland, 34-700
        • Investigator site 202
      • Rzeszow, Poland, 35-612
        • Investigator site 209
  • Spain
      • Madrid, Spain, 28046
        • Investigator Site 401
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Investigator site 114
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Investigator Site 134
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Investigator Site 121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liprotamase
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Drug: Liprotamase
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Other Names:
  • Sollpura

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
Time Frame: 12 months
Descriptive analysis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (ESTIMATE)

July 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-EPI3334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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