Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hydroxychloroquine · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| Hydroxychloroquine | ACTIVE_COMPARATOR | Administered pre-transplant through 3 months after surgery. |
| Placebo | PLACEBO_COMPARATOR | Placebo treatment following the same schedule as Arm 1 (i.e. Hydroxychloroquine). |
| Name | Type | Description |
|---|---|---|
| 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. |
| Placebo | DRUG | Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery. |
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 * Panc...