Autopsy report · NCT03174522

The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM

“Independent Data Monitoring Committee recommendation to stop due to futility”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month after it had already started.
• Ran for about 5 years 10 months before it stopped.
• 49 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Ixaka Ltd

Sponsor type

Industry

Conditions

Peripheral Arterial Disease (PAD); Diabetes Mellitus (DM); Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Cardiovascular Disease; Critical Limb Ischemia (CLI)

Interventions

REX-001; Placebo

Participants

49

Sites

15

Countries

Czechia, Hungary, Netherlands, Portugal, Spain, United Kingdom

Trials that died the same way

• Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes
  “following a recommendation from the data safety and monitoring board due to safety concerns and a tendency towards futility.” (69% match in meaning)
• To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
  “This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.” (68% match in meaning)
• Lithium in Multiple System Atrophy
  “Data Monitoring Committee decision on 22nd August 2011 for safety issues” (67% match in meaning)
• Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression
  “Interim Analysis reviewed by Data Monitoring Committee indicated futility” (63% match in meaning)
• Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
  “Data Safety Monitoring Board (DSMB) recommended stopping study due to futility” (60% 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.