CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Hydroxychloroquine +1 moredrug
Likely dose
Hydroxychloroquine 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03283566
NCT03283566Phase 2Completed
CompareCT.gov

Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing Total Pancreatectomy and Autologous Islet Transplantation: A Clinical, Molecular, and Genomic Study

The Cleveland Clinic·interventional·Posted Sep 14, 2017·Updated Apr 8, 2022

In Brief

A Phase 2 clinical trial evaluating Hydroxychloroquine and Placebo for Chronic Pancreatitis and Insulin Dependent Diabetes. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pancreatitis, Insulin Dependent Diabetes
CountriesUnited States
CollaboratorsAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Stanford University

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 14, 2017
Enrollment StartOct 3, 2017
Primary CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.8 years ago

Interventions

Hydroxychloroquinedrug

Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.

Placebodrug

Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.