Autopsy report · NCT01310738

Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil

“DSMB recommendation based on programmed interim analysis.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 4 years before it stopped.
• 378 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

University of Brasilia

Sponsor type

University, hospital or other

Conditions

Visceral Leishmaniasis

Interventions

Antimoniate of N-methylglucamine; amphotericin B deoxycholate; Liposomal amphotericin B; Liposomal amphotericin B; Antimoniate of N-methylglucamine

Participants

378

Sites

5

Countries

Brazil

Trials that died the same way

• Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial
  “DSMB recommendation following interim analysis” (92% match in meaning)
• Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO
  “DSMB recommendation (futility)” (73% match in meaning)
• A Phase III Trial of Lorenzo's Oil in Adrenomyeloneuropathy
  “Upon recommendation of DSMB” (71% match in meaning)
• Thiamine as a Metabolic Resuscitator After Cardiac Arrest
  “DSMB recommendation based on differing mortality in a subgroup analysis” (69% match in meaning)
• Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis
  “The study treminated early according to DSMB recommendantions” (59% 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.