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ALTU-135 Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency (DIGEST [E])

This study is currently recruiting participants.
Verified by Altus Pharmaceuticals, August 2007

Sponsored by: Altus Pharmaceuticals
Information provided by: Altus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00449878
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Altus Pharmaceuticals:

Study Start Date:   May 2007

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

Criteria

Inclusion Criteria:

  1. ≥ 7 years of age.
  2. Females of childbearing potential must be willing to use birth control (intrauterine device [IUD]; oral, transdermal or parenteral contraceptives; abstinence).
  3. Diagnosis of CF based upon the following criteria:

    1. two clinical features consistent with CF; and
    2. either genotype with two identifiable mutations consistent with CF;
    3. or sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis.
  4. Clinically stable with no evidence of acute upper or lower respiratory tract infection.
  5. PI determined by fecal elastase < 100 µg/g stool measured at the Screening Visit.
  6. Able to take pancreatic enzyme supplementation in the form of capsules.
  7. Able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the Investigator.
  8. Willing and able to provide informed consent or assent.
  9. Baseline coefficient of fat absorption (CFA) ≤ 80%.

Exclusion Criteria:

  1. < 7 years of age.
  2. CFA > 80% at Baseline.
  3. Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control (IUD; oral, transdermal or parenteral contraceptives; abstinence) during the study.
  4. History of fibrosing colonopathy.
  5. 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.

  6. Any acute or chronic diarrheal illness unrelated to PI (e.g. infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease).
  7. Unable to discontinue enteral tube feedings during the study.
  8. Known hypersensitivity to food additives.
  9. Inability to consume the PP diets, in the judgment of the Investigator.
  10. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the Screening Visit.
  11. ALT or AST level > 5x upper limit of normal (ULN), or total bilirubin level > 1.5x ULN at the Screening Visit or at Baseline (except for patients with Gilbert Syndrome).
  12. Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF(‡).
  13. Distal intestinal obstruction syndrome (DIOS) in the last six months prior to the Screening Visit.
  14. Unable to discontinue the use of pancreatic enzymes.
  15. Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient.
  16. Patient is unlikely to complete the study, as determined by the Investigator.

(‡) 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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449878

Contacts
Contact: Candida Fratazzi, MD, Medical Monitor     617.299.2816     cfratazzi@altus.com    

Show 29 study locations  Show 29 Study Locations

Sponsors and Collaborators
Altus Pharmaceuticals
  More Information


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

Keywords provided by Altus Pharmaceuticals:
cystic fibrosis-related pancreatic insufficiency  

Study placed in the following topic categories:
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on October 31, 2008




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