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Sponsored by: |
Alnara Pharmaceuticals |
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Information provided by: | Alnara Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00449904 |
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with CF-related exocrine PI. This is a multi-center trial with a one year duration. Approximately 200 patients with CF-related exocrine PI will be enrolled into the study.
Condition | Intervention | Phase |
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Cystic Fibrosis Exocrine Pancreatic Insufficiency |
Drug: ALTU-135 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency |
Enrollment: | 215 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 7 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
two clinical features consistent with CF; and either
Sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis.
Exclusion Criteria:
Note: Significant resection of the bowel is defined as any resection of the terminal ileum, or ileo-cecal valve. Patients who have had qualitative, long-term changes in nutritional status after any other bowel resection (e.g., increased, or new, need for supplementation compared to pre-op in order to maintain the same nutritional status) should also be excluded.
Principal Investigator: | Drucy Borowitz, MD | Women and Children's Hospital of Buffalo |
Responsible Party: | Alnara Pharmaceuticals, Clinical Development ( Candida Fratazzi, MD, Senior Medical Director ) |
Study ID Numbers: | 0000767 |
Study First Received: | March 19, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00449904 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cystic fibrosis-related exocrine pancreatic insufficiency |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Exocrine Pancreatic Insufficiency |
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Exocrine Pancreatic Insufficiency |