NCT00449878

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

March 19, 2007

Last Update Submit

October 15, 2014

Conditions

Cystic FibrosisExocrine Pancreatic Insufficiency

Keywords

cystic fibrosis-related pancreatic insufficiency

Outcome Measures

Primary Outcomes (1)

  • Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA)

    Open label baseline, end of 6 day double blind treatment period

Secondary Outcomes (4)

  • Change from open label baseline to end of 6 day double blind treatment period in Coefficient of nitrogen absorption (CNA)

    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

    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

    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

    Open label baseline, end of 6 day double blind treatment period

Study Arms (2)

Liprotamase

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Double Blind Treatment Period: Placebo (microcrystalline cellulose) administered orally with each of three meals and two snacks daily for 6 days.

Drug: Placebo

Interventions

LiprotamaseDRUG

Administered orally

Also known as: ALTU-135, LY3031642, TheraCLEC - Total
Liprotamase
PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

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.

Los Angeles, California, 90027, United States

Location

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, 94305, United States

Location

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, 80218, United States

Location

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.

Jacksonville, Florida, 32247, United States

Location

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, 33136, United States

Location

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.

Atlanta, Georgia, 30322, United States

Location

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.

Glenview, Illinois, 60025, United States

Location

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.

Indianapolis, Indiana, 46202, United States

Location

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 City, Iowa, 52242, United States

Location

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.

Ann Arbor, Michigan, 26506, United States

Location

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, 48224, United States

Location

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, 49503, United States

Location

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, 49007, United States

Location

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.

Minneapolis, Minnesota, 55455, United States

Location

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.

Jackson, Mississippi, 39216, United States

Location

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.

Hanover, New Hampshire, 03756, United States

Location

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.

Buffalo, New York, 14215, United States

Location

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.

Durham, North Carolina, 27710, United States

Location

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.

Cincinnati, Ohio, 45267, United States

Location

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, 44106, United States

Location

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, 45404, United States

Location

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.

Portland, Oregon, 97201, United States

Location

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.

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

Sioux Falls, South Dakota, 57117, United States

Location

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.

Memphis, Tennessee, 38105, United States

Location

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.

Salt Lake City, Utah, 84132, United States

Location

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.

Morgantown, West Virginia, 26506, United States

Location

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.

Madison, Wisconsin, 53792, United States

Location

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, 53226, United States

Location

Related Publications (1)

  • 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.

    PMID: 32761612DERIVED

MeSH Terms

Conditions

Cystic FibrosisExocrine Pancreatic Insufficiency

Interventions

liprotamase lipase

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 21, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

US(29)