Autopsy report · NCT04741542

Safety of SP-420 in the Treatment of Transfusional Iron Overload

“Study is on hold by FDA in the US.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 2 years 10 months before it stopped.
• 2 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

The University of Texas Health Science Center at San Antonio

Sponsor type

University, hospital or other

Conditions

Iron Overload

Interventions

SP-420

Participants

2

Sites

1

Countries

United States

Trials that died the same way

• MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly
  “FDA hold on the project” (80% match in meaning)
• A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma
  “Full clinical hold from FDA” (78% match in meaning)
• Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
  “FDA Clinical Hold” (77% match in meaning)
• DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)
  “FDA Clinical Hold as of 12/21/07 due to safety concerns” (77% match in meaning)
• A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
  “FDA requested us to stop the study” (75% 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.