Open-Label Phase III Long-Term Safety Trial of Liprotamase

Phase 3

Completed

• Conditions: Cystic Fibrosis; Exocrine Pancreatic Insufficiency
• Interventions: Drug: Liprotamase

• Registration Number: NCT00449904
• 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 patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Study Start: 2007-06
• Primary Completion: 2009-04
• Study Completion: 2009-04
• 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: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

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Exclusion Criteria

• Age <7 years
• Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control
• Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening
• History of fibrosing colonopathy
• History of liver transplant, lung transplant or significant surgical resection of the bowel
• Any chronic diarrheal illness unrelated to PI
• Abnormal liver function (except for patients with Gilbert Syndrome)
• Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF
• Unable to discontinue enteral tube feedings during the study
• 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
• Baseline coefficient of fat absorption (CFA) ≥ 93% from the Phase III efficacy study
• Patient is unlikely to complete the study, as determined by the Investigator

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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

Secondary Outcome Measures

Name	Time	Method
Change from baseline up to 12 months in Body Mass Index (BMI) Z-scores	Baseline, up to 12 months
Change from baseline up to 12 months in body weight Z-scores	Baseline, up to 12 months
Change from baseline up to 12 months in height Z-scores (up to 17 years in participants age)	Baseline, up to 12 months

Trial Locations

Locations (2)

University of 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.; 🇺🇸 Burlington, Vermont, United States

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.; 🇺🇸 Madison, Wisconsin, United States