Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

Study Description

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Brief Summary:

The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis; Pancreatic Insufficiency	Drug: Liprotamase; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	129 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
Study Start Date :	June 2004
Actual Primary Completion Date :	March 2005
Actual Study Completion Date :	March 2005

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Low Liprotamase Dose; Liprotamase in a fixed combination of lipase (5,000 units), protease (5,000 units) and amylase (750 units) administered orally (one Size 5 capsule of liprotamase and five Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days	Drug: Liprotamase; Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase); Other Names: ALTU-135; LY3031642; TheraCLEC - Total Drug: Placebo; Administered orally in either Size 2 or Size 5 capsules
Experimental: Mid Liprotamase Dose; Liprotamase in a fixed combination of lipase (25,000 units), protease (25,000 units) and amylase (3,750 units) administered orally (one Size 5 capsule of liprotamase, one Size 2 capsule of liprotamase, and four Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days	Drug: Liprotamase; Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase); Other Names: ALTU-135; LY3031642; TheraCLEC - Total Drug: Placebo; Administered orally in either Size 2 or Size 5 capsules
Experimental: High Liprotamase Dose; Liprotamase in a fixed combination of lipase (100,000 units), protease (100,000 units) and amylase (15,000 units) administered orally (one Size 5 capsule of placebo and five Size 2 capsules of liprotamase) with each of three meals and two snacks daily for 28 days	Drug: Liprotamase; Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase); Other Names: ALTU-135; LY3031642; TheraCLEC - Total Drug: Placebo; Administered orally in either Size 2 or Size 5 capsules

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline up to 19 days in Coefficient of fat absorption (CFA) [ Time Frame: Baseline, up to 19 days ]

Secondary Outcome Measures :

1. Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA) [ Time Frame: Baseline, up to 19 days ]
2. Change from baseline up to 19 days in stool weight [ Time Frame: Baseline, up to 19 days ]
3. Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores [ Time Frame: Baseline, 29 days ]
4. Change from baseline up to 19 days in number of Stools [ Time Frame: Baseline, up to 19 days ]
5. Change from baseline to 28 days in maximum change in glucose response [ Time Frame: Baseline through 28 days ]

Eligibility Criteria

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Ages Eligible for Study:	7 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Pancreatic insufficiency (PI) documented by fecal elastase <100 mcg/gram measured at screening

• Diagnosis of CF based upon the following criteria:

  • two clinical features consistent with CF AND
  • either genotype with two identifiable mutations consistent with CF OR
  • sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis
• Forced Expiratory Volume Over One Second (FEV1) ≥30% predicted
• Clinically stable with no evidence of acute upper or lower respiratory tract infection

Exclusion Criteria:

• Pregnancy, breastfeeding or of childbearing potential and/or not willing to use accepted methods of birth control during enrollment in the study
• History of fibrosing colonopathy
• History of liver transplant or lung transplant
• Unable to discontinue enteral tube feedings during the study
• Subject weight <40 kg
• Known hypersensitivity to food additives
• Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
• Unable to discontinue the use of pancreatic enzymes for a 72-hour period or any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 27 Study Locations

Sponsors and Collaborators

Anthera Pharmaceuticals

Cystic Fibrosis Foundation Therapeutics

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00095732 History of Changes
Other Study ID Numbers:	14269; I5L-MC-TCAA ( Other Identifier: Eli Lilly and Company ); TC-2A ( Other Identifier: Altus/Alnara )
First Posted:	November 9, 2004
Last Update Posted:	October 17, 2014
Last Verified:	October 2014

Keywords provided by Anthera Pharmaceuticals:

Pancreatic Insufficiency; Cystic Fibrosis; Enzymes

Additional relevant MeSH terms:

Fibrosis; Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Pathologic Processes; Pancreatic Diseases	Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases