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NCT03283566 · ClinicalTrials.gov registry record · Phase 2

Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT

A Phase 2 study of Chronic Pancreatitis and Insulin Dependent Diabetes, sponsored by The Cleveland Clinic.

Completed
Registry status
Phase 2
Development phase
9
Enrollment target
1
Study location

NCT03283566: Completed Phase 2 study of Chronic Pancreatitis and Insulin Dependent Diabetes, sponsored by The Cleveland Clinic.

NCT03283566 is a Phase 2 study of Chronic Pancreatitis and Insulin Dependent Diabetes that has completed, run by The Cleveland Clinic. The registered enrollment target is 9 participants, below the 689-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03283566, a Phase 2 study of Chronic Pancreatitis and Insulin Dependent Diabetes, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
Phase 2
Development phase
9 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

HCQ-treated compared to placebo arm. This outcome measure was reported in Mean and Standard deviation looking at C peptide/glucose secretion at 90 mins during mixed meal test adjusted for IEG/Kg (islet cell equivalency) infused to the patient.

Conditions Studied

Chronic Pancreatitis Insulin Dependent Diabetes

Interventions

  • DRUG Placebo
  • DRUG Hydroxychloroquine

Study Locations (1)

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2017-10-03
Est. Completion 2020-05-31
Phase Phase 2
The Cleveland Clinic

688 total trials

What the finished NCT03283566 record still lists

NCT03283566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 689-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Chronic Pancreatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03283566 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT03283566 about?

NCT03283566 is a clinical study titled "Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT". 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 ...

What is the current status of trial NCT03283566?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2017-10-03. Estimated completion is 2020-05-31.

What conditions does trial NCT03283566 study?

This clinical trial studies the following conditions: Chronic Pancreatitis, Insulin Dependent Diabetes.

What interventions are being tested in trial NCT03283566?

The interventions under investigation include: Placebo (DRUG), Hydroxychloroquine (DRUG).

Who is sponsoring clinical trial NCT03283566?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03283566 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Pancreatitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03283566's enrollment target sits among peer trials

9 40th of 42 higher than 2 of 42 other Chronic Pancreatitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Pancreatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03283566, the US trial registry maintained by the National Library of Medicine. NCT03283566 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.