Status:
COMPLETED
Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis
Lead Sponsor:
Quince Therapeutics S.p.A.
Collaborating Sponsors:
Casa Sollievo della Sofferenza IRCCS
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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: * D...
Detailed Description
This was a single-center, placebo-controlled, randomised, phase II explorative study with the aim to investigate the ability of the new steroid delivery system to induce or maintain remission in stero...
Eligibility Criteria
Inclusion
- 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
- 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 \< 90 bpm, ESR \> 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.
Key Trial Info
Start Date :
July 22 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01171807
Start Date
July 22 2003
End Date
May 15 2007
Last Update
September 24 2024
Active Locations (1)
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1
Casa Sollievo della Sofferenza Hospital
San Giovanni Rotondo, Italy, 71013