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Study Title: RG1068 (Synthetic Human Secretin) – Enhanced MRCP in the Evaluation of Subjects with a History of Acute or Acute Recurrent Pancreatitis
Category: Gastroenterology

Currently accepting participants?
Not at this time.

Principal Investigator: Richard Kozarek
Study Coordinator: Alice Stead
Phone: 206 341 1450
Email: alice.stead@vmmc.org

What is the RG1068 (Synthetic Human Secretin) – Enhanced MRCP in the Evaluation of Subjects with a History of Acute or Acute Recurrent Pancreatitis study?

Secretin is a naturally occurring peptide hormone that rapidly promotes the movement of pancreatic fluid into the pancreatic ducts, and thereby enhances the magnetic resonance imaging (MRI) signal, and improves the delineation of both normal and abnormal duct structures. The goal of this clinical study is to demonstrate that RG1068, a synthetic human secretin, in conjunction with MRCP provides an improvement in diagnostic utility compared to unenhanced MRCP for subjects with pancreatic duct abnormalities. This phase III trial is being undertaken to confirm that RG1068 enhances the sensitivity of MRCP in detecting pancreatic duct abnormalities without loss of specificity, using an ERCP-based truth standard.

Who can participate?

The study will be conducted in males and females age 18 and older with a history of acute or acute recurrent pancreatitis.

Study Summary:

If you participate in the study, you will have a magnetic resonance cholangiopancreatography (MRCP) in addition to your ERCP. MRCP uses magnetic resonance imaging (MRI, the use of magnetic waves to look at soft tissues of the body) to produce detailed pictures of the pancreas so that doctors can look for diseases or abnormalities. To enhance the MRI images in this study, you will be given RG1068, a type of secretin, during your MRCP. Secretin is a compound made in your body that helps release fluids in the pancreas. RG1068 is a synthetic (man-made) secretin.

Detailed Study Description:

(No information)

Study Design: Interventional
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Acute or acute recurrent pancreatitis
Intervention Type: Procedure/Surgery
Intervention Name: RG1068
Gender: Male and Female
Age group: Interventional
Sponsor: Repligen Corporation


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