Phase III ALTU-135 CP Safety Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00500084
• Date of registration: 10/07/2007
• Prospective Registration: Yes
• Primary sponsor: Anthera Pharmaceuticals
• Public title: Phase III ALTU-135 CP Safety Trial DIGEST CP
• Scientific 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
• Date of first enrolment: December 2007
• Target sample size: 39
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00500084
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Exocrine Pancreatic Insufficiency

Intervention(s)

Drug: Liprotamase

Primary Outcome(s)

Number of participants with an adverse event [Time Frame: Baseline up to 12 months]

Secondary ID(s)

I5L-MC-TCAD

810

14294

Source(s) of Monetary Support

Please refer to primary and secondary sponsors