Autopsy report · NCT00450333

Dynepo Infrequent Dosing Study

“The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA”

The sponsor’s own words in the registry.

Life of this trial

• Registered 5 months after it had already started.
• Ran for about 1 year 9 months before it stopped.
• 407 participants enrolled.
• Results were posted on the registry 1 year 3 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Shire

Sponsor type

Industry

Conditions

Anemia; Kidney Failure

Interventions

Dynepo (Epoetin delta); Dynepo; Dynepo; Dynepo

Participants

407

Sites

53

Countries

Austria, Belgium, France, Germany, Italy, Spain, United Kingdom

Trials that died the same way

• An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity
  “The study was terminated early due to sponsor decision unrelated to safety or efficacy findings” (72% match in meaning)
• Liver Transplantation With Tregs at UCSF
  “The study was terminated by the Sponsor prior to any participants receiving the investigational product.” (72% match in meaning)
• An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
  “The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study” (70% match in meaning)
• A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
  “The study terminated for safety reasons” (70% match in meaning)
• PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency
  “The study was terminated by the sponsor prior to planned completion based on a review of the data across indications and overall program considerations. Study termination was not related to participant safety.” (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.