Phase III ALTU-135 CP Safety Trial

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