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

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)

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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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

Jacksonville, Florida, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Shreveport, Louisiana, United States

Boston, Massachusetts, United States

St Louis, Missouri, United States

Lebanon, New Hampshire, United States

Mineola, New York, United States

...and 1 more locations