At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dexamethasone Intra-Erythrocyte Therapy in Patients With Chron's Disease or Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating Dex 21-P and Placebo for Ulcerative Colitis. Completed, enrolled 33 participants across 1 site.
Detailed Summary
Objectives: The primary objective of this trial was to evaluate the patients response rate at the end of the study. Patients were considered responder if one of the following conditions occurs: * Disease remission (Powell Tuck ≤ 3 or CDAI \< 150) and withdrawal of oral steroids therapy from at least the second treatment procedure; * Disease marked improvement versus basal conditions (at least 5 point decrease in Powell Tuck index or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure. Secondary objectives: * to evaluate the endogenous cortisole production after receiving the study treatment * to evaluate the inflammatory indexes (ESR and CPR) after receiving the study treatment * to evaluate the endoscopic remission in patients suffering from mesalazine refractory Ulcerative Colitis * to evaluate the safety of dexamethasone intra-erythrocyte therapy with particular attention to steroid-related adverse events.
Study Details
Timeline
Interventions
At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded erythrocytes were immediately re-infused by using a suitable filter.
Patients assigned to placebo arm performed the same procedure as the patients assigned to the DEX 21-P group without loading in the Red Blood Cells the Dex 21-P