Phase III ALTU-135 CP Safety Trial

Phase 3TerminatedNCT00500084

Anthera Pharmaceuticals39 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

39

Conditions

Exocrine Pancreatic Insufficiency

Interventions

LiprotamaseDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (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, United States

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, United States

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, United States

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, United States

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, United States

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, United States

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, United States

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, United States

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, United States

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, United States

...and 1 more locations

Outcomes

Primary Outcomes

Number of participants with an adverse event

Time frame: Baseline up to 12 months

Data from ClinicalTrials.gov

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