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

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.

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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RG1068 (Synthetic Human Secretin)

Drug

Single-dose, IV infusion

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

Sponsors and collaborators

Lead sponsor

Repligen Corporation

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 17, 2008
Registry last updated: Dec 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed