Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This will be a pilot, 12-month phase II, open label, randomized, two-arm, single-blinded, placebo-controlled, parallel clinical trial of individuals undergoing TPAIT (Total Pancreatectomy and Autologous Islet Transplantation) for treatment of chronic pancreatitis (CP). The two study arms consist of HCQ-treated (Hydroxychloroquine) and placebo-treated individuals. The purpose of this study is to investigate the effects of HCQ administration compared to placebo on islet cell function post-autologous transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborators: Allegheny Singer Research Institute; Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); Stanford University
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• Clinically confirmed diagnosis of chronic pancreatitis (CP)

• Intractable abdominal pain

• History of failed operation(s) for CP

• Recurrent acute pancreatitis

• HbA1c <8.0%

• Sustained alcohol remission

• Chronic narcotic use

Exclusion Criteria:

• Insulin dependence

• Pancreatic carcinoma

• Pancreatic mass suspicious for carcinoma

• Cirrhosis

• Portal hypertension

• Continued alcohol abuse

• Manufacturer's product label-contraindicated use of HCQ

• History of retinopathy

• Actual weight at enrollment <40 Kg