Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT

NCT03283566 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-912
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pancreatectomy; Autologous Islet Transplantation; Pancreatitis; Diabetes; Hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Secondary Outcomes (2)

• C-peptide AUC Response to MMTT

  12 months

• Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass

  12 months

Study Arms (2)

Hydroxychloroquine

ACTIVE COMPARATOR

Administered pre-transplant through 3 months after surgery.

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine).

Drug: Placebo

Interventions

Hydroxychloroquine DRUG

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.

Also known as: Plaquenil

Hydroxychloroquine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): collaborator
• Stanford University: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Diabetes Mellitus, Type 1; Pancreatitis; Diabetes Mellitus

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: EMI Research Director
• Organization: Cleveland Clinic Foundation, Department of Endocroine and Metabolism

jenkink@ccf.org

216 445-3757

Study Officials

• Betul Hatipoglu, MD

  Staff

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be single-blinded. The PI, biostatistician who will analyze the data, consultants, and technicians running assays will be blinded to the study arm into which the subjects have been randomized. An alphanumeric identifier that refers to the study subject without any indicators of study arm allocation will be used. Only the surgeons and the research coordinator, but not the personnel conducting the metabolic studies, will be un-blinded as to the study arm randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label, randomized, two-arm, single-blinded, placebo-controlled, parallel

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 14, 2017
• Study Start: October 3, 2017
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: April 8, 2022
• Results First Posted: March 11, 2022

Record last verified: 2022-04

Locations

US (1)