EASY: Extended Access to Sollpura Over Years

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase III ALTU-135 CP Safety Trial

NCT00500084

Exocrine Pancreatic Insufficiency

TERMINATED PHASE3

A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

NCT00662675

Exocrine Pancreatic Insufficiency Steatorrhea Malabsorption Syndromes +1 more

COMPLETED PHASE3

An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption

NCT00217204

Cystic Fibrosis Steatorrhea

COMPLETED PHASE2

Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

NCT00095732

Cystic Fibrosis Pancreatic Insufficiency

COMPLETED PHASE2

Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis

NCT00432861

Cystic Fibrosis Pancreatic Insufficiency

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exocrine Pancreatic Insufficiency Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Liprotamase

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

Group Type EXPERIMENTAL

Liprotamase

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Liprotamase

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sollpura

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No