Status:
COMPLETED
Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
Lead Sponsor:
Anthera Pharmaceuticals
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Pancreatic Insufficiency
Eligibility:
All Genders
7+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.
Eligibility Criteria
Inclusion
- Pancreatic insufficiency (PI) documented by fecal elastase \<100 mcg/gram measured at screening
- 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
- Forced Expiratory Volume Over One Second (FEV1) ≥30% predicted
- Clinically stable with no evidence of acute upper or lower respiratory tract infection
Exclusion
- Pregnancy, breastfeeding or of childbearing potential and/or not willing to use accepted methods of birth control during enrollment in the study
- History of fibrosing colonopathy
- History of liver transplant or lung transplant
- Unable to discontinue enteral tube feedings during the study
- Subject weight \<40 kg
- Known hypersensitivity to food additives
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
- Unable to discontinue the use of pancreatic enzymes for a 72-hour period or any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00095732
Start Date
June 1 2004
End Date
March 1 2005
Last Update
October 17 2014
Active Locations (27)
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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.
Birmingham, Alabama, United States, 35233
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.
Palo Alto, California, United States, 94304
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.
Gainesville, Florida, United States, 32610