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Sponsored by: |
Altus Pharmaceuticals |
Information provided by: | Altus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00449878 |
This is a clinical trial which will evaluate the efficacy and safety of ALTU-135 treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI). It will be conducted as a multicenter study with participating sites having expertise in treating patients with CF. The study hypothesis is that the mean change in coefficient of fat absorption for the patients treated with ALTU-135 is significantly different from that for the patients treated with placebo.
Condition | Intervention | Phase |
Cystic Fibrosis Exocrine Pancreatic Insufficiency |
Drug: ALTU-135 |
Phase III |
Genetics Home Reference related topics: | cystic fibrosis |
MedlinePlus related topics: | Cystic Fibrosis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency |
Ages Eligible for Study: | 7 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of CF based upon the following criteria:
Exclusion Criteria:
History of liver transplant, lung transplant or significant surgical resection of the bowel.
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.
(‡) Eligible patients with ALT or AST level > 3x to 5x ULN at the Screening Visit or at Baseline will be tested for viral hepatitis. Other diagnostic testing may be performed at the discretion of the Investigator.
Contact: Candida Fratazzi, MD, Medical Monitor | 617.299.2816 | cfratazzi@altus.com |
Show 29 Study Locations |
Altus Pharmaceuticals |
Study ID Numbers: | 0000726 |
First Received: | March 19, 2007 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00449878 |
Health Authority: | United States: Food and Drug Administration |
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