Phase III ALTU-135 CP Safety Trial

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthera Pharmaceuticals

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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