Phase III ALTU-135 CP Safety Trial (DIGEST CP)

This study has been terminated.
(Sponsor decision.)
Sponsor:
Information provided by:
Alnara Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00500084
First received: July 10, 2007
Last updated: December 13, 2010
Last verified: December 2010
  Purpose

This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in CP patients with exocrine PI. This is a multi-center trial with a one year duration to evaluate the long-term safety and tolerability of ALTU-135 treatment.


Condition Intervention Phase
Pancreatic Insufficiency
Drug: Liprotamase (formerly ALTU-135)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Alnara Pharmaceuticals:

Enrollment: 41
Study Start Date: July 2007
Estimated Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females ≥ 18 years of age.
  • Females of childbearing potential must be willing to use birth control(IUD; oral, transdermal or parenteral contraceptives; abstinence).
  • Fecal elastase levels < 100 µg/g stool measured at the Screening Visit.
  • Diagnosis of chronic pancreatitis or status post pancreatectomy. Diagnosis of chronic pancreatitis is based upon at least one of the following:

    • Endoscopic retrograde pancreatography, MRCP or ultrasound demonstrating ductal changes consistant with chronic pancreatitis
    • Abnormal Secretin Pancreatic Function test with a peak bicarbonate concentration < 75 mEq/L
    • Presence of pathognomic pancreatic calcifications
    • Pathology proven chronic pancreatitis on surgical specimens
  • Able to perform the testing and procedures required for the study, as judged by the investigator.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Males and females < 18 years of age.
  • Pregnancy, breastfeeding or of childbearing potential and not willing to use methods of birth control (oral, transdermal or parenteral) during the study.
  • History of liver transplant.
  • Liver transaminases >3x ULN or total bilirubin >1.5x ULN at the Screening Visit or at Baseline.
  • Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the Screening Visit.
  • 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.
  • Any history of pancreatic cancer except for patients with IPMT who are status post total or partial pancreatectomy resulting in pancreatic insufficiency.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500084

Locations
United States, Connecticut
Medical Research Instiute of Conneticut
Hamden, Connecticut, United States, 06518
United States, Florida
Shands Jacksonville Hospital
Jacksonville, Florida, United States, 32207
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Beth Israel Deaconess Hospital
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63104
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Winthrop-University Hospital
Mineola, New York, United States, 11501
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Alnara Pharmaceuticals
  More Information

No publications provided

Responsible Party: Robert Gallotto, Alnara Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00500084     History of Changes
Other Study ID Numbers: 0000810
Study First Received: July 10, 2007
Last Updated: December 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alnara Pharmaceuticals:
Chronic Pancreatitis
Pancreatectomy

Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014