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Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas

Primary Purpose

Pancreatitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
RG1068 (synthetic human secretin)
Sponsored by
Repligen Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatitis focused on measuring secretin, RG1068, MRCP, pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of pancreatitis
  • Medically stable
  • Able to give informed consent

Exclusion Criteria:

  • Prior history of pancreatic resection
  • Prior history of pancreatic duct drainage procedure
  • Presence of a pancreatic stent
  • Unstable cardiovascular disease
  • Any contraindication to MRI procedure
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities.

    Secondary Outcome Measures

    The secondary outcome measure will assess safety

    Full Information

    First Posted
    April 15, 2008
    Last Updated
    December 2, 2009
    Sponsor
    Repligen Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00660335
    Brief Title
    Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas
    Official Title
    Phase III Study to Demonstrate the Efficacy and Safety of RG1068 (Synthetic Human Secretin)- Enhanced Magnetic Resonance Cholangiopancreatography (MRCP) in the Evaluation of Subjects With a History of Acute or Acute Recurrent Pancreatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Repligen Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic human secretin) with MRCP in subjects with abnormalities of the pancreas.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatitis
    Keywords
    secretin, RG1068, MRCP, pancreas

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    258 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    RG1068 (synthetic human secretin)
    Intervention Description
    Single-dose, IV infusion
    Primary Outcome Measure Information:
    Title
    The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities.
    Time Frame
    0 - 10 minutes post dose
    Secondary Outcome Measure Information:
    Title
    The secondary outcome measure will assess safety
    Time Frame
    up to 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of pancreatitis Medically stable Able to give informed consent Exclusion Criteria: Prior history of pancreatic resection Prior history of pancreatic duct drainage procedure Presence of a pancreatic stent Unstable cardiovascular disease Any contraindication to MRI procedure Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David R Jacoby, MD, PhD
    Organizational Affiliation
    Repligen Corporation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24906040
    Citation
    Sherman S, Freeman ML, Tarnasky PR, Wilcox CM, Kulkarni A, Aisen AM, Jacoby D, Kozarek RA. Administration of secretin (RG1068) increases the sensitivity of detection of duct abnormalities by magnetic resonance cholangiopancreatography in patients with pancreatitis. Gastroenterology. 2014 Sep;147(3):646-654.e2. doi: 10.1053/j.gastro.2014.05.035. Epub 2014 Jun 4.
    Results Reference
    derived

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    Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas

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