Phase 2
Completed N=33
Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis
Source: ClinicalTrials.gov NCT01171807 ↗Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Sep 2024
Primary outcomePrimary: The Proportion of Patients Responders to Dex 21-P vs Placebo — 15; 1; 6; 11 Participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients Responders to Dex 21-P vs Placebo |
15; 1; 6; 11 | <0.001 sig |
| SECONDARY Change From Baseline in Endogenous Cortisole Blood Level After Receiving the Study Treatment |
3.3; 2.3 | — |
| SECONDARY Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: Erythrocyte Sedimentation Rate (ESR) |
-4.9; -9.3 | — |
| SECONDARY Change From Baseline in Inflammatory Indexes After Receiving the Study Treatment: C-reactive Protein (CRP) |
-0.5; -2.2 | — |
| SECONDARY Count of Partecipants, Suffering From Mesalazine Refractory UC, With Modification in Endoscopic Result (Baron Score) |
1; 0; 0; 1; 0; 2 | — |
| SECONDARY Number of Patients Experiencing at Least One TEAE (Not Steroid-related) |
11; 8; 0; 1 | — |
| SECONDARY Number of Patients Experiencing at Least One TEAE (Steroid-related) |
3; 3 | — |
Eligibility Criteria
Inclusion Criteria
- More than 18 years of age
- Patients suffering from one of the following chronic inflammatory intestinal disease:
- Steroid-dependent Chron's Disease or Ulcerative Colitis following ECCO definition or mild-moderate active UC ( Powell Tuck between 3 and 14- an index of 14 was allowed; endoscopic Baron score >1) refractory to mesalazine.
- Disease extension over the rectum (at least 15 cm) in patients suffering from Ulcerative Colitis
- Patients willing and be able to give written informed consent.
Exclusion Criteria
- Intestinal sub occlusion or a suspected abdomen abscess or a severe degree of the disease (CDAI > 450) in patient suffering from Chron's Disease
- Patient affected by a severe Ulcerative Colitis (more than 6 evacuations of liquid, mucous-blooding stools combined at least one systemic sign as body temperature > 37.8 °C, heart rate 30 mm/h or haemoglobin < 10.5 g/dL)
- Severe concurrent disease(s) as:
- Medullar deficit: white blood cells < 3000/mm3; platelets < 75000/mm3; haemoglobin < 10 g/dL;
- Hepatic diseases presenting total bilirubin ≥ 3 mg/dL; AST (GOT) ≥ 5 UNL; alkaline phosphatase ≥ 5 UNL:
- Renal failure with serum creatinine ≥ 3 mg/dL;
- Heart failure
- Respiratory failure
- Disabling neurological diseases
- Neoplasia
- Patient deemed candidate to surgery due to Chron's Disease or Ulcerative Colitis
- Chronic alcohol or drug abuse
- Patient for whom the use of steroids is contraindicated (e.g. systemic infections)
- Treatment with Infliximab in the previous 4 months
- Pregnant woman or female for whom the possibility of a pregnancy during the study could not be excluded.
- Non-collaborating patient or subject unable to regularly undergo the scheduled study procedures.
Data sourced from ClinicalTrials.gov (NCT01171807). 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. Informational only — not medical advice.