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Completed

NCT Number: NCT00095732

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Exocrine Pancreatic Insufficiency Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pancreatic Insufficiency Respiratory Tract Diseases

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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., Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liprotamase

Drug

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

Placebo

Drug

Administered orally in either Size 2 or Size 5 capsules

Primary outcomes

  1. Change from baseline up to 19 days in Coefficient of fat absorption (CFA)

    Time frame: Baseline, up to 19 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Anthera Pharmaceuticals

Industry

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 9, 2004
Registry last updated
Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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