Autopsy report · NCT06601907

Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder

“An unplanned interim futility analysis was initiated due to differential dropout and participant feedback. The probability of achieving the pre-specified effect size was very low, and following DSMB review, the trial was terminated early.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 10 months before it stopped.
• 286 participants enrolled.
• Results were posted on the registry 8 months after it ended.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Gaia AG

Sponsor type

Industry

Conditions

Borderline Personality Disorder (BPD)

Interventions

alivis

Participants

286

Sites

1

Countries

Germany

Trials that died the same way

• CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)
  “Study was terminated after the planned interim analysis as the pre-defined futility threshold was met” (76% 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.” (76% match in meaning)
• Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
  “Based on the outcome of a planned interim analysis, the study was stopped early due to futility.” (72% match in meaning)
• 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.” (70% match in meaning)
• Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
  “Based on results of an interim analysis, the study was halted for futility” (69% 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.