Phase III ALTU-135 CP Safety Trial
Stopped early · Phase 3
Conditions studied: Exocrine Pancreatic Insufficiency
In brief
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic Insufficiency (PI).
Key facts
- Study ID
- NCT00500084
- Run by
- Anthera Pharmaceuticals
- People needed
- 39
- Starts
- 2007-12-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2014-10-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Females of childbearing potential must be willing to use birth control
- Fecal elastase levels < 100 micrograms per gram (µg/g) stool measured at screening
- Able to perform the testing and procedures required for the study, as judged by the investigator
- Diagnosis of chronic pancreatitis or status post pancreatectomy
- Diagnosis of chronic pancreatitis is based upon at least one of the following:
- Endoscopic retrograde pancreatography, magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
- Abnormal Secretin Pancreatic Function test with a peak bicarbonate concentration < 75 milliequivalents per liter (mEq/L)
- Presence of pathognomic pancreatic calcifications
- Pathology proven chronic pancreatitis on surgical specimens
You may not qualify if…
- Pregnancy, breastfeeding or of childbearing potential and not willing to use methods of birth control during the study
- History of liver transplant
- Liver transaminases >3x Upper Limit Normal (ULN) or total bilirubin >1.5x ULN at screening or at Baseline (except for patients with Gilbert's Syndrome)
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
- 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
- History of pancreatic cancer
- Diagnosis of cystic fibrosis
- Active alcohol or drug abuse
- Presence of any medical condition that is likely to preclude survival for 12 months
- Demonstrated unlikely to comply with protocol requirements or complete the study
Where it is running
- 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. — Hamden, Connecticut, United States
- 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
- 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. — Chicago, Illinois, United States
- 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. — Indianapolis, Indiana, United States
- 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. — Shreveport, Louisiana, United States
- 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. — Boston, Massachusetts, United States
- 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. — Boston, Massachusetts, United States
- 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. — St Louis, Missouri, United States
- 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. — Lebanon, New Hampshire, United States
- 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. — Mineola, New York, United States
- 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. — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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