Status:
COMPLETED
Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Lead Sponsor:
Anthera Pharmaceuticals
Conditions:
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Eligibility:
All Genders
7+ years
Phase:
PHASE3
Brief Summary
This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).
Detailed Description
This trial is divided into four distinct periods: 1. Baseline Period during which each patient is taken off pancreatic enzyme medications. 2. An Open-Label Treatment Period during which all patients ...
Eligibility Criteria
Inclusion
- Females of childbearing potential must be willing to use birth control
- Diagnosis of CF based upon the following criteria:
- two clinical features consistent with CF; and
- either genotype with two identifiable mutations consistent with CF, OR
- sweat chloride \>60 mEq/L by quantitative pilocarpine iontophoresis
- Clinically stable with no evidence of acute upper or lower respiratory tract infection
- PI determined by fecal elastase \<100 µg/g stool measured at screening
- Able to take pancreatic enzyme supplementation in the form of capsules
- Able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the Investigator
- Baseline coefficient of fat absorption (CFA) less than or equal to 80%
Exclusion
- CFA \>80% at Baseline
- Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study
- History of fibrosing colonopathy
- History of liver transplant, lung transplant or significant surgical resection of the bowel
- Any acute or chronic diarrheal illness unrelated to PI
- Unable to discontinue enteral tube feedings during the study
- Known hypersensitivity to food additives
- Inability to consume the diet required by the study, in the judgment of the Investigator
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
- Abnormal liver function (except for patients with Gilbert Syndrome)
- Signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to CF
- Distal intestinal obstruction syndrome (DIOS) in the last six months prior to screening
- Unable to discontinue the use of pancreatic enzymes
- Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
- Patient is unlikely to complete the study, as determined by the Investigator
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00449878
Start Date
May 1 2007
End Date
June 1 2008
Last Update
October 24 2014
Active Locations (29)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States, 90027
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stanford, California, United States, 94305
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Denver, Colorado, United States, 80218
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jacksonville, Florida, United States, 32247