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

Primary Purpose

Cystic Fibrosis, Exocrine Pancreatic Insufficiency

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Liprotamase

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis-related exocrine pancreatic insufficiency

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liprotamase

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with an adverse event

Secondary Outcome Measures

Change from baseline up to 12 months in body weight Z-scores

Change from baseline up to 12 months in height Z-scores (up to 17 years in participants age)

Change from baseline up to 12 months in Body Mass Index (BMI) Z-scores

Full Information

NCT ID

NCT00449904

First Posted

March 19, 2007

Last Updated

October 15, 2014

Sponsor

Anthera Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00449904

Brief Title

Open-Label Phase III Long-Term Safety Trial of Liprotamase

Acronym

DIGEST

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 Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Exocrine Pancreatic Insufficiency

Keywords

Cystic fibrosis-related exocrine pancreatic insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

214 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liprotamase

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Liprotamase

Other Intervention Name(s)

ALTU-135, LY3031642, TheraCLEC-total

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Number of participants with an adverse event

Time Frame

Baseline up to 12 months

Secondary Outcome Measure Information:

Title

Change from baseline up to 12 months in body weight Z-scores

Time Frame

Baseline, up to 12 months

Title

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

Title

Change from baseline up to 12 months in Body Mass Index (BMI) Z-scores

Time Frame

Baseline, up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

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.

City

Oakland

State/Province

California

ZIP/Postal Code

94611

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32247

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

City

Glenview

State/Province

Illinois

ZIP/Postal Code

60025

Country

United States

Facility Name

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

26506

Country

United States

Facility Name

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48224

Country

United States

Facility Name

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

City

Hanover

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

City

Long Branch

State/Province

New Jersey

ZIP/Postal Code

07740

Country

United States

Facility Name

City

Buffalo

State/Province

New York

ZIP/Postal Code

14222

Country

United States

Facility Name

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45404

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97201

Country

United States

Facility Name

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57117

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

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.

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792-9988

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Open-Label Phase III Long-Term Safety Trial of Liprotamase

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