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

Repligen Corporation258 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

258

Conditions

Pancreatitis

Interventions

RG1068 (synthetic human secretin)DRUG

Single-dose, IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

The secondary outcome measure will assess safety

Time frame: up to 30 days

Data from ClinicalTrials.gov

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