Open-Label Phase III Long-Term Safety Trial of Liprotamase (DIGEST)
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ClinicalTrials.gov Identifier: NCT00449904 |
Recruitment Status :
Completed
First Posted : March 21, 2007
Last Update Posted : October 24, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis Exocrine Pancreatic Insufficiency | Drug: Liprotamase | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 214 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Liprotamase
Liprotamase is a fixed combination of lipase (32,500 units), protease (25,000 units) and amylase (3,750 units) administered orally with each of three meals and two snacks daily for 12 months.
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Drug: Liprotamase
Administered orally
Other Names:
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- Number of participants with an adverse event [ Time Frame: Baseline up to 12 months ]
- Change from baseline up to 12 months in body weight Z-scores [ Time Frame: Baseline, up to 12 months ]
- Change from baseline up to 12 months in height Z-scores (up to 17 years in participants age) [ Time Frame: Baseline, up to 12 months ]
- Change from baseline up to 12 months in Body Mass Index (BMI) Z-scores [ Time Frame: Baseline, up to 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 7 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Females of childbearing potential must be willing to use birth control
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Diagnosis of CF based upon the following criteria:
- Two clinical features consistent with CF; and either
- A genotype with two identifiable mutations consistent with CF, or
- Sweat chloride > 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis.
- Clinically stable with no evidence of acute upper or lower respiratory tract infection
- Exocrine pancreatic insufficiency (PI) determined by fecal elastase < 100 micrograms per gram (µg/g) measured at Screening
- Able to take pancreatic enzyme supplementation in the form of capsules
- Able to perform the testing and procedures required for this study, as judged by the Investigator
Exclusion Criteria:
- Age <7 years
- Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening
- History of fibrosing colonopathy
- History of liver transplant, lung transplant or significant surgical resection of the bowel
- Any chronic diarrheal illness unrelated to PI
- Abnormal liver function (except for patients with Gilbert Syndrome)
- Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF
- Unable to discontinue enteral tube feedings during the study
- 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
- Baseline coefficient of fat absorption (CFA) ≥ 93% from the Phase III efficacy study
- Patient is unlikely to complete the study, as determined by the Investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449904
United States, California | |
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. | |
Oakland, California, United States, 94611 | |
United States, Colorado | |
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Denver, Colorado, United States, 80206 | |
United States, Florida | |
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Jacksonville, Florida, United States, 32247 | |
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Miami, Florida, United States, 33136 | |
United States, Georgia | |
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Atlanta, Georgia, United States, 30322 | |
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Augusta, Georgia, United States, 30912 | |
United States, Idaho | |
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Boise, Idaho, United States, 83712 | |
United States, Illinois | |
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Chicago, Illinois, United States, 60614 | |
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Glenview, Illinois, United States, 60025 | |
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Niles, Illinois, United States, 60714 | |
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Oak Lawn, Illinois, United States, 60453 | |
United States, Indiana | |
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Indianapolis, Indiana, United States, 46202 | |
United States, Iowa | |
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Iowa City, Iowa, United States, 52242 | |
United States, Massachusetts | |
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Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
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Ann Arbor, Michigan, United States, 26506 | |
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Detroit, Michigan, United States, 48201 | |
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Detroit, Michigan, United States, 48224 | |
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Kalamazoo, Michigan, United States, 49007 | |
United States, Minnesota | |
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Minneapolis, Minnesota, United States, 55455 | |
United States, Mississippi | |
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Jackson, Mississippi, United States, 39216 | |
United States, Nebraska | |
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Omaha, Nebraska, United States, 68198 | |
United States, New Hampshire | |
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Hanover, New Hampshire, United States, 03756 | |
United States, New Jersey | |
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Long Branch, New Jersey, United States, 07740 | |
United States, New York | |
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Buffalo, New York, United States, 14222 | |
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Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
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Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
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Akron, Ohio, United States, 44308 | |
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Cincinnati, Ohio, United States, 45267 | |
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Dayton, Ohio, United States, 45404 | |
United States, Oklahoma | |
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Oklahoma City, Oklahoma, United States, 73104 | |
United States, Oregon | |
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Portland, Oregon, United States, 97201 | |
United States, South Dakota | |
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Sioux Falls, South Dakota, United States, 57117 | |
United States, Tennessee | |
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Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
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Houston, Texas, United States, 77030 | |
United States, Utah | |
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Salt Lake City, Utah, United States, 84132 | |
United States, Vermont | |
University of 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. | |
Burlington, Vermont, United States, 05401 | |
United States, Virginia | |
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Charlottesville, Virginia, United States, 22908 | |
United States, West Virginia | |
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Morgantown, West Virginia, United States, 26506 | |
United States, Wisconsin | |
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Madison, Wisconsin, United States, 53792-9988 |
Responsible Party: | Anthera Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00449904 |
Other Study ID Numbers: |
14298 I5L-MC-TCAC ( Other Identifier: Eli Lilly and Company ) 767 ( Other Identifier: Altus/Alnara ) |
First Posted: | March 21, 2007 Key Record Dates |
Last Update Posted: | October 24, 2014 |
Last Verified: | October 2014 |
Cystic fibrosis-related exocrine pancreatic insufficiency |
Cystic Fibrosis Exocrine Pancreatic Insufficiency Fibrosis Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |