Autopsy report · NCT04867837

Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

“Following Interim Analysis IDMEAC concluded:1-No safety concerns 2-Suspend enrolment: Futility based on treatment effect size at interim analysis. Enrollment was suspended on 22DEC25. Study was terminated FEB2026. Final analysis is planned in Q2 2026”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 4 years 4 months before it stopped.
• 100 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Octapharma

Sponsor type

Industry

Conditions

Acute Major Bleeding

Interventions

Octaplex

Participants

100

Sites

63

Countries

Austria, Bosnia and Herzegovina, Croatia, France, Georgia, Germany, Italy, Poland, Spain, Turkey (Türkiye), Ukraine, United Kingdom and more

Trials that died the same way

• A Study of Isatuximab-based Therapy in Participants With Lymphoma
  “Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern” (68% match in meaning)
• A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
  “Study was stopped following interim analysis.” (68% match in meaning)
• A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
  “This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.” (68% match in meaning)
• 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” (68% match in meaning)
• Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
  “The study was terminated based on the results of a planned interim analysis that showed futility of efficacy.” (67% 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.