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RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

NCT03051490·50 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

Anthera Pharmaceuticals

Age

7–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride
Fecal elastase \<100 mcg/g stool
Good disease control with porcine PERT prior to enrollment
Good nutritional status

You may not be if

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
Forced expiratory volume in 1 second (FEV1) \<30%

The record

StatusUnknown

PhasePhase 3

Taking part140

StartedApr 2017

UpdatedMar 8, 2018

Conditions

Exocrine Pancreatic Insufficiency Cystic Fibrosis

Where50

Investigator Site 139
Little Rock, Arkansas, United States
Investigator Site #123
Long Beach, California, United States
Investigator Site 107
Los Angeles, California, United States

Clareo Health | RESULT: Reliable, Emergent Solution Using Liprotamase Treatment