Phase 2
N=9
Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT
Chronic Pancreatitis · Insulin Dependent Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03283566 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT — .000000077; 0.000000079 ng/mg glucose/IEQ/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydroxychloroquine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quotient of Stimulated C-peptide/Glucose Level Normalized for IEQ/Kg Infused in Response to MMTT |
.000000077; 0.000000079 | — |
| SECONDARY C-peptide AUC Response to MMTT |
813; 588 | 0.739 |
| SECONDARY Ratio of C-peptide AUC to Glucose AUC in Response to MMTT Adjusted for Infused Islet Cell Mass |
0.00091; 0.00222 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03283566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.