Phase III ALTU-135 CP Safety Trial (DIGEST CP)

Inclusion Criteria:

• Males and females ≥ 18 years of age.
• Females of childbearing potential must be willing to use birth control(IUD; oral, transdermal or parenteral contraceptives; abstinence).
• Fecal elastase levels < 100 µg/g stool measured at the Screening Visit.

• Diagnosis of chronic pancreatitis or status post pancreatectomy. Diagnosis of chronic pancreatitis is based upon at least one of the following:

  • Endoscopic retrograde pancreatography, MRCP or ultrasound demonstrating ductal changes consistant with chronic pancreatitis
  • Abnormal Secretin Pancreatic Function test with a peak bicarbonate concentration < 75 mEq/L
  • Presence of pathognomic pancreatic calcifications
  • Pathology proven chronic pancreatitis on surgical specimens
• Able to perform the testing and procedures required for the study, as judged by the investigator.
• Willing and able to provide written informed consent.

Exclusion Criteria:

• Males and females < 18 years of age.
• Pregnancy, breastfeeding or of childbearing potential and not willing to use methods of birth control (oral, transdermal or parenteral) during the study.
• History of liver transplant.
• Liver transaminases >3x ULN or total bilirubin >1.5x ULN at the Screening Visit or at Baseline.
• Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the Screening Visit.
• 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.
• Any history of pancreatic cancer except for patients with IPMT who are status post total or partial pancreatectomy resulting in pancreatic insufficiency.
• 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.