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Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT

NCT03283566 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-04-08

Study results available
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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.

Conditions

  • Chronic Pancreatitis
  • Insulin Dependent Diabetes

Interventions

DRUG

Hydroxychloroquine

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Betul Hatipoglu, MD · Staff

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2020-05-31
Completion
2020-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283566 on ClinicalTrials.gov