Phase III ALTU-135 CP Safety Trial

Phase 3

Terminated

• Conditions: Exocrine Pancreatic Insufficiency
• Interventions: Drug: Liprotamase

• Registration Number: NCT00500084
• Lead Sponsor: Anthera Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-12
• Study Start: 2007-12
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2010-12-13
• Disposition First Submitted QC: 2010-12-13
• Disposition First Posted: 2010-12-16
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liprotamase	Liprotamase	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

Primary Outcome Measures

Name	Time	Method
Number of participants with an adverse event	Baseline up to 12 months

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Cincinnati, Ohio, United States