NCT03283566

Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT

Completed Phase 2 Results posted Last updated 8 April 2022

What this trial tests

Phase 2 trial testing Hydroxychloroquine in Chronic Pancreatitis in 9 participants. Completed in 31 May 2020.

Timeline

3 October 2017

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	9
Start date	3 October 2017
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
• Placebo

Conditions studied

• Chronic Pancreatitis — all drugs for Chronic Pancreatitis →
• Insulin Dependent Diabetes — all drugs for Insulin Dependent Diabetes →

Sponsor

The Cleveland Clinic

Who can join

Adults 18 to 65, any sex, with Chronic Pancreatitis or Insulin Dependent Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT Primary · 12 months

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.

Group	Value	95% CI
Hydroxychloroquine	.000000077	± .000000096
Placebo	0.000000079	± .00000012

C-peptide AUC Response to MMTT Secondary · 12 months

HCQ-treated compared to placebo arm. We used a standard, 5 hour Mixed meal tolerance test (MMT). Blood draws were taken every 15 mins for the first hours, then every 30 mins the second hour, then hourly until completion.

Group	Value	95% CI
Hydroxychloroquine	813	± 463
Placebo	588	± 391

Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass Secondary · 12 months

C-peptide, ng/mL/min/IEQ/kg iAUC post-MMTT. Our measurement can be reported in area under the curve for C-peptide normalized for glucose values as well as Islet cell mass infused to the patient in order to compare placebo vs intervention arms.

Group	Value	95% CI
Hydroxychloroquine	0.00091	± 0.0006
Placebo	0.00222	± 0.0029

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potential Effect of Hydroxychloroquine in Diabetes Mellitus: A Systematic Review on Preclinical and Clinical Trial Studies.
   Wondafrash DZ, Desalegn TZ, Yimer EM, Tsige AG, et al · · 2020 · cited 39× · PMID 32190699 · DOI 10.1155/2020/5214751
2. Management of chronic pancreatitis: recent advances and future prospects.
   Han C, Lv YW, Hu LH. · · 2024 · cited 5× · PMID 38406795 · DOI 10.1177/17562848241234480
3. Bioenergetics of Islet Preparations in a Pilot Clinical Trial of Peri-Transplant Hydroxychloroquine for Autologous Islet Transplantation.
   McDowell RE, Ali KF, Lad S, San Martin VT, et al · · 2021 · cited 3× · PMID 34757864 · DOI 10.1177/09636897211057440