Autopsy report · NCT00792740

Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease

“As no safety warnings were detected, Interim analysis from the first 40 patients recommends to stop the trial for futility”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 1 month after it had already started.
• Ran for about 1 year 5 months before it stopped.
• 51 participants enrolled.
• Results were posted on the registry 14 years 4 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Italfarmaco

Sponsor type

Industry

Conditions

Crohn's Disease

Interventions

ITF2357; Placebo

Participants

51

Sites

10

Countries

Belgium, Italy, Netherlands

Trials that died the same way

• A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
  “The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.” (85% match in meaning)
• Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
  “This trial was terminated following a futility analysis confirming futility of continuing the study” (78% match in meaning)
• Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia
  “Discontinued after interim analysis for futility; no treatment successes observed in the first 12 patients” (75% match in meaning)
• Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
  “The independent DSMB recommended that the study be stopped for futility following interim efficacy analysis.” (75% match in meaning)
• Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
  “The trial was stopped for futility in view of the results of the anticipated analysis” (75% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.