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Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency (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: NCT00449878
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 19, 2007
First Posted Date  ICMJE March 21, 2007
Last Update Posted Date October 24, 2014
Study Start Date  ICMJE May 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA) [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
  • Change from open label baseline to end of 6 day double blind treatment period in Coefficient of nitrogen absorption (CNA) [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]
  • Change from open label baseline to end of 6 day double blind treatment period in number of stools [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]
  • Change from open label baseline to end of 6 day double blind treatment period in stool weight [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]
  • Change from open label baseline to end of 6 day double blind treatment period in maximum blood glucose [ Time Frame: Open label baseline, end of 6 day double blind treatment period ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Official Title  ICMJE 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
Brief Summary This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).
Detailed Description

This trial is divided into four distinct periods:

  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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Exocrine Pancreatic Insufficiency
Intervention  ICMJE
  • Drug: Liprotamase
    Administered orally
    Other Names:
    • ALTU-135
    • LY3031642
    • TheraCLEC - Total
  • Drug: Placebo
    Administered orally
Study Arms  ICMJE
  • Experimental: 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.

    Intervention: Drug: Liprotamase
  • Placebo Comparator: Placebo
    Double Blind Treatment Period: Placebo (microcrystalline cellulose) administered orally with each of three meals and two snacks daily for 6 days.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
163
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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:

  • CFA >80% at Baseline
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00449878
Other Study ID Numbers  ICMJE 14293
I5L-MC-TCAB ( Other Identifier: Eli Lilly and Company )
726 ( Other Identifier: Altus/Alnara )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Anthera Pharmaceuticals
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Anthera Pharmaceuticals
Original Study Sponsor  ICMJE Altus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Anthera Pharmaceuticals
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP