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

This study has been completed.

First Received on November 9, 2004. Last Updated on March 24, 2010 History of Changes

Sponsor:	Altus Pharmaceuticals
Collaborator:	Cystic Fibrosis Foundation
Information provided by:	Altus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00095732

Purpose

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	Intervention	Phase
Cystic Fibrosis Pancreatic Insufficiency	Drug: TheraCLEC™ - Total	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Theraclec

U.S. FDA Resources

Further study details as provided by Altus Pharmaceuticals:

Primary Outcome Measures:

Coefficient of fat absorption (CFA)

Secondary Outcome Measures:

Coefficient of nitrogen absorption (CNA)
Weight of stools
Number of stools
Starch digestion and carbohydrate absorption as measured by blood glucose response
Quality of life as measured by the Cystic Fibrosis Questionnaire (CFQ)

Estimated Enrollment:	126
Study Start Date:	June 2004
Estimated Study Completion Date:	March 2005

Eligibility

Ages Eligible for Study:	7 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pancreatic insufficiency (PI) documented by fecal elastase <100 mg/gm measured at the Screening Visit
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.
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 the Screening Visit
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095732

Show 27 Study Locations

Sponsors and Collaborators

Altus Pharmaceuticals

Cystic Fibrosis Foundation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00095732 History of Changes
Other Study ID Numbers:	TC-2A
Study First Received:	November 9, 2004
Last Updated:	March 24, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Altus Pharmaceuticals:

Enzymes
Pancreatic Insufficiency
Cystic Fibrosis

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases

Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012