Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency (DIGEST)

October 15, 2014 updated by: Anthera Pharmaceuticals

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

This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Inpatient, Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo.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

Interventional

Enrollment (Actual)

163

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • 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, 94305
        • 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.
    • Colorado
      • Denver, Colorado, United States, 80218
        • 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.
    • Florida
      • Jacksonville, Florida, United States, 32247
        • 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.
      • Miami, Florida, United States, 33136
        • 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.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • 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.
    • Illinois
      • Glenview, Illinois, United States, 60025
        • 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.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • 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.
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • 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.
    • Michigan
      • Ann Arbor, Michigan, United States, 26506
        • 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.
      • Detroit, Michigan, United States, 48224
        • 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.
      • Grand Rapids, Michigan, United States, 49503
        • 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.
      • Kalamazoo, Michigan, United States, 49007
        • 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.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • 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.
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • 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.
    • New Hampshire
      • Hanover, New Hampshire, United States, 03756
        • 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.
    • New York
      • Buffalo, New York, United States, 14215
        • 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.
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • 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.
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • 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.
      • Cleveland, Ohio, United States, 44106
        • 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.
      • Dayton, Ohio, United States, 45404
        • 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.
    • Oregon
      • Portland, Oregon, United States, 97201
        • 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.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • 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.
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • 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.
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • 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.
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • 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.
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • 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.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • 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.
      • Milwaukee, Wisconsin, United States, 53226
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Liprotamase
Administered orally
Other Names:
  • ALTU-135
  • LY3031642
  • TheraCLEC - Total
PLACEBO_COMPARATOR: Placebo
Double Blind Treatment Period: Placebo (microcrystalline cellulose) administered orally with each of three meals and two snacks daily for 6 days.
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Open label baseline, end of 6 day double blind treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Open label baseline, end of 6 day double blind treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

March 19, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (ESTIMATE)

March 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14293
  • I5L-MC-TCAB (OTHER: Eli Lilly and Company)
  • 726 (OTHER: Altus/Alnara)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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