CompletedPhase 2

Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT

United States9 participantsStarted 2017-10-03

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT

Timeframe: 12 months

Trial details

NCT IDNCT03283566

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-31

Results submitted2021-09-15

View on ClinicalTrials.gov More Chronic Pancreatitis trials