Exocrine Pancreatic Insufficiency
Conditions
Keywords
Chronic Pancreatitis, Pancreatectomy
Brief 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).
Interventions
DRUGLiprotamase
Administered orally
Sponsors
Anthera Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with an adverse event | Baseline up to 12 months |
Countries
United States
Outcome results
None listed