NCT00500084

Brief Summary

This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic Insufficiency (PI).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
terminated

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

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

July 10, 2007

Last Update Submit

October 15, 2014

Conditions

Exocrine Pancreatic Insufficiency

Keywords

Chronic PancreatitisPancreatectomy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with an adverse event

    Baseline up to 12 months

Study Arms (1)

Liprotamase

EXPERIMENTAL

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

Interventions

LiprotamaseDRUG

Administered orally

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females of childbearing potential must be willing to use birth control
  • Fecal elastase levels \< 100 micrograms per gram (µg/g) stool measured at screening
  • Able to perform the testing and procedures required for the study, as judged by the investigator
  • Diagnosis of chronic pancreatitis or status post pancreatectomy
  • Diagnosis of chronic pancreatitis is based upon at least one of the following:
  • Endoscopic retrograde pancreatography, magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
  • Abnormal Secretin Pancreatic Function test with a peak bicarbonate concentration \< 75 milliequivalents per liter (mEq/L)
  • Presence of pathognomic pancreatic calcifications
  • Pathology proven chronic pancreatitis on surgical specimens

You may not qualify if:

  • Pregnancy, breastfeeding or of childbearing potential and not willing to use methods of birth control during the study
  • History of liver transplant
  • Liver transaminases \>3x Upper Limit Normal (ULN) or total bilirubin \>1.5x ULN at screening or at Baseline (except for patients with Gilbert's Syndrome)
  • Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
  • 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
  • History of pancreatic cancer
  • Diagnosis of cystic fibrosis
  • Active alcohol or drug abuse
  • Presence of any medical condition that is likely to preclude survival for 12 months
  • Demonstrated unlikely to comply with protocol requirements or complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

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.

Hamden, Connecticut, 06518, 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, 32207, 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.

Chicago, Illinois, 60612, 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.

Shreveport, Louisiana, 71103, 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.

Boston, Massachusetts, 02115, 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.

Boston, Massachusetts, 02215, 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.

St Louis, Missouri, 63104, 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.

Lebanon, 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.

Mineola, New York, 11501, 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

MeSH Terms

Conditions

Exocrine Pancreatic InsufficiencyPancreatitis, Chronic

Interventions

liprotamase lipase

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

December 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

US(11)