Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
NCT ID: NCT00449878
Last Updated: 2014-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
163 participants
INTERVENTIONAL
2007-05-31
2008-06-30
Brief Summary
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Detailed Description
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1. Baseline Period during which each patient is taken off pancreatic enzyme medications.
2. An Open-Label Treatment Period during which all patients will receive ALTU-135 (liprotamase).
3. Inpatient, Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo.
4. Second Open-Label Treatment Period during which all patients will resume treatment with ALTU-135 (liprotamase).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Liprotamase
Liprotamase is a fixed combination of lipase (32,500 units), protease (25,000 units) and amylase (3,750 units).
Open Label Period: Liprotamase administered orally with each of three meals and two snacks daily for 21 days.
Double Blind Treatment Period: Administered orally with each of three meals and two snacks daily for 6 days.
Second Open Label Period: Administered orally with each of three meals and two snacks daily for 7 days.
Liprotamase
Administered orally
Placebo
Double Blind Treatment Period: Placebo (microcrystalline cellulose) administered orally with each of three meals and two snacks daily for 6 days.
Placebo
Administered orally
Interventions
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Liprotamase
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Clinically stable with no evidence of acute upper or lower respiratory tract infection
* PI determined by fecal elastase \<100 µg/g stool measured at screening
* Able to take pancreatic enzyme supplementation in the form of capsules
* Able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the Investigator
* Baseline coefficient of fat absorption (CFA) less than or equal to 80%
Exclusion Criteria
* Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study
* History of fibrosing colonopathy
* History of liver transplant, lung transplant or significant surgical resection of the bowel
* Any acute or chronic diarrheal illness unrelated to PI
* Unable to discontinue enteral tube feedings during the study
* Known hypersensitivity to food additives
* Inability to consume the diet required by the study, in the judgment of the Investigator
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
* Abnormal liver function (except for patients with Gilbert Syndrome)
* Signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to CF
* Distal intestinal obstruction syndrome (DIOS) in the last six months prior to screening
* Unable to discontinue the use of pancreatic enzymes
* 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
* Patient is unlikely to complete the study, as determined by the Investigator
7 Years
ALL
No
Sponsors
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Anthera Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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.
Los Angeles, California, United States
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.
Stanford, California, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Glenview, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Kalamazoo, Michigan, United States
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Minneapolis, Minnesota, United States
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Jackson, Mississippi, United States
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Hanover, New Hampshire, United States
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Buffalo, New York, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Memphis, Tennessee, United States
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Salt Lake City, Utah, United States
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Morgantown, West Virginia, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
Countries
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References
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Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
Other Identifiers
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I5L-MC-TCAB
Identifier Type: OTHER
Identifier Source: secondary_id
726
Identifier Type: OTHER
Identifier Source: secondary_id
14293
Identifier Type: -
Identifier Source: org_study_id
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