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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00095732
• Date of registration: 09/11/2004
• Prospective Registration: No
• Primary sponsor: Anthera Pharmaceuticals
• Public title: Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
• Scientific title: A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
• Date of first enrolment: June 2004
• Target sample size: 129
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00095732
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 7 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatic Insufficiency

Cystic Fibrosis

Intervention(s)

Drug: Placebo

Drug: Liprotamase

Primary Outcome(s)

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

Secondary Outcome(s)

Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores [Time Frame: Baseline, 29 days]

Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA) [Time Frame: Baseline, up to 19 days]

Change from baseline to 28 days in maximum change in glucose response [Time Frame: Baseline through 28 days]

Change from baseline up to 19 days in number of Stools [Time Frame: Baseline, up to 19 days]

Change from baseline up to 19 days in stool weight [Time Frame: Baseline, up to 19 days]

Secondary ID(s)

14269

I5L-MC-TCAA

TC-2A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation Therapeutics