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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02734810
First received: April 6, 2016
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Exocrine Pancreatic Insufficiency
Cystic Fibrosis
Drug: Liprotamase Powder for Oral Solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Safety in Part A (subjects aged > 7 years), as measured by number of participants with adverse events or laboratory abnormalities [ Time Frame: 1 week ]
    Descriptive analysis

  • Coefficient of Fat Absorption (CFA) in Part B (subjects aged 28 days - < 7 years) [ Time Frame: 7 weeks ]
    Descriptive analysis

  • Safety in Part B (subjects aged 28 days - < 7 years), as measured by number of participants with adverse events or laboratory abnormalities [ Time Frame: 24 weeks ]
    Descriptive analysis


Secondary Outcome Measures:
  • Symptoms of malabsorption [ Time Frame: 7 weeks ]
    Change from baseline

  • Growth metrics (weight, Height BMI) in Part B (subjects aged 28 days - < 7 years) [ Time Frame: 24 weeks ]
    Change from baseline


Enrollment: 15
Actual Study Start Date: June 2016
Study Completion Date: February 28, 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02734810

  Show 21 Study Locations
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02734810     History of Changes
Other Study ID Numbers: AN-EPI3332
Study First Received: April 6, 2016
Last Updated: May 19, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 24, 2017