Status:
COMPLETED
Open-Label Phase III Long-Term Safety Trial of Liprotamase
Lead Sponsor:
Anthera Pharmaceuticals
Conditions:
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Eligibility:
All Genders
7+ years
Phase:
PHASE3
Brief Summary
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- A genotype with two identifiable mutations consistent with CF, or
- Sweat chloride \> 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis.
- Clinically stable with no evidence of acute upper or lower respiratory tract infection
- Exocrine pancreatic insufficiency (PI) determined by fecal elastase \< 100 micrograms per gram (µg/g) measured at Screening
- Able to take pancreatic enzyme supplementation in the form of capsules
- Able to perform the testing and procedures required for this study, as judged by the Investigator
- Exclusion Criteria:
- Age \<7 years
- Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening
- History of fibrosing colonopathy
- History of liver transplant, lung transplant or significant surgical resection of the bowel
- Any chronic diarrheal illness unrelated to PI
- Abnormal liver function (except for patients with Gilbert Syndrome)
- Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF
- Unable to discontinue enteral tube feedings during the study
- 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
- Baseline coefficient of fat absorption (CFA) ≥ 93% from the Phase III efficacy study
- Patient is unlikely to complete the study, as determined by the Investigator
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00449904
Start Date
June 1 2007
End Date
April 1 2009
Last Update
October 24 2014
Active Locations (39)
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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.
Oakland, California, United States, 94611
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.
Denver, Colorado, United States, 80206
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.
Jacksonville, Florida, United States, 32247
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.
Miami, Florida, United States, 33136