Autopsy report · NCT04056611

Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

“A strategic decision was made to discontinue the study. The decision was not based on a safety concern.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 2 years 1 month before it stopped.
• 3 participants enrolled.
• Results were posted on the registry 1 year 2 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Janssen Sciences Ireland UC

Sponsor type

Industry

Conditions

Respiratory Syncytial Virus Infections

Interventions

JNJ-53718678 250 mg; Placebo; JNJ-53718678 125 mg

Participants

3

Sites

69

Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, France, Israel, Italy, Japan, Malaysia, Netherlands, South Korea and more

Trials that died the same way

• A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD
  “It has been made the strategic decision to terminate the study. This decision to terminate the study early is not being made for safety reasons.” (82% match in meaning)
• Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
  “Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.” (80% match in meaning)
• A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
  “The study was discontinued due to a business decision; no safety concerns were noted.” (75% match in meaning)
• TT-816 As Monotherapy or in Combination with a PD-1 Inhibitor in Patients with Advanced Cancers (SEABEAM) (MK3475-E88)
  “Company operational decision. Decision to stop study is not due to safety or efficacy concerns.” (75% match in meaning)
• Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
  “Decision was made to not go forward with the study” (74% 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.