ClinicalTrials.gov
ClinicalTrials.gov Menu

SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis (SIMPLICITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02734810
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

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. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency Cystic Fibrosis Drug: Liprotamase Powder for Oral Solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Part A
Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age
Drug: Liprotamase Powder for Oral Solution
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
Other Name: Liprotamase
Experimental: Part B
Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years
Drug: Liprotamase Powder for Oral Solution
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
Other Name: Liprotamase



Primary Outcome Measures :
  1. Safety [ Time Frame: 1 week ]
    Number of subjects reporting 1 or more adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For Part A: males or females ≥7 years of age
  • For Part B: males or females 28 days to <7 years
  • Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
  • Low fecal elastase
  • Fair-to-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734810


  Show 21 Study Locations
Sponsors and Collaborators
Anthera Pharmaceuticals

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02734810     History of Changes
Other Study ID Numbers: AN-EPI3332
First Posted: April 12, 2016    Key Record Dates
Results First Posted: May 11, 2018
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anthera Pharmaceuticals:
Exocrine Pancreatic Insufficiency
Cystic Fibrosis
Liprotamase
Pancreatic Enzyme Replacement Therapy (PERT)

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions