Status:
COMPLETED
Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Stanford University
Conditions:
Chronic Pancreatitis
Insulin Dependent Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 Autologo...
Detailed Description
A compelling level of evidence exists on the effects of the innate immunity-driven inflammation on the decline of functional beta cell mass in the autologous transplant setting. The investigators hypo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03283566
Start Date
October 3 2017
End Date
May 31 2020
Last Update
April 8 2022
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195