Clinical trial NCT00500084: Phase III ALTU-135 CP Safety Trial
Official title: An Open-Label Clinical Study Evaluating the Long Term Safety of ALTU-135 in the Treatment of Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Exocrine Pancreatic Insufficiency
Keywords: Chronic Pancreatitis
Pancreatectomy
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with an adverse event
timeFrame: Baseline up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamden
country: United States
facility: 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.
state: Connecticut
city: Jacksonville
country: United States
facility: 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.
state: Florida
city: Chicago
country: United States
facility: 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.
state: Illinois
city: Indianapolis
country: United States
facility: 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.
state: Indiana
city: Shreveport
country: United States
facility: 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.
state: Louisiana
city: Boston
country: United States
facility: 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.
state: Massachusetts
city: Boston
country: United States
facility: 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.
state: Massachusetts
city: St. Louis
country: United States
facility: 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.
state: Missouri
city: Lebanon
country: United States
facility: 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.
state: New Hampshire
city: Mineola
country: United States
facility: 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.
state: New York
city: Cincinnati
country: United States
facility: 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.
state: Ohio
Study officials:
References: