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Open-Label Phase III Long-Term Safety Trial of Liprotamase (DIGEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00449904
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Study Description
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Brief Summary:
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Exocrine Pancreatic Insufficiency Drug: Liprotamase Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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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.
 Drug: Liprotamase
Administered orally
Other Names:
  • ALTU-135
  • LY3031642
  • TheraCLEC-total


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with an adverse event [ Time Frame: Baseline up to 12 months ]

Secondary Outcome Measures :
  1. Change from baseline up to 12 months in body weight Z-scores [ Time Frame: Baseline, up to 12 months ]
  2. 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 ]
  3. Change from baseline up to 12 months in Body Mass Index (BMI) Z-scores [ Time Frame: Baseline, up to 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Females of childbearing potential must be willing to use birth control

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
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.
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
Sponsors and Collaborators
Anthera Pharmaceuticals
More Information
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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
Keywords provided by Anthera Pharmaceuticals:
Cystic fibrosis-related exocrine pancreatic insufficiency
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Pathologic Processes
Pancreatic Diseases
 Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases