Phase III ALTU-135 CP Safety Trial

Study Overview
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Brief Summary
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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).

Official Title
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An Open-Label Clinical Study Evaluating the Long Term Safety of ALTU-135 in the Treatment of Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy

Conditions
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Exocrine Pancreatic Insufficiency

Intervention / Treatment
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* Drug: Liprotamase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liprotamase<br>Liprotamase is a fixed combination of lipase (32,500 units), protease (25,000 units) and amylase (3,750 units) administered orally with each of three meals and two snacks daily for 12 months | Drug: Liprotamase<br>* Administered orally<br>* Other names: TheraCLEC - Total;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an adverse event |  | Baseline up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pancreatitis, Pancreatectomy