Autopsy report · NCT00377455

Placebo Controlled Trial of Bosentan in Scleroderma Patients

“Study was terminated due to inadequate enrolment”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 3 years 6 months before it stopped.
• 5 participants enrolled.
• Results were posted on the registry 1 year 4 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Georgetown University

Sponsor type

University, hospital or other

Conditions

Systemic Scleroderma; Pulmonary Hypertension

Interventions

Bosentan; Placebo

Participants

5

Sites

2

Countries

United States

Trials that died the same way

• A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation
  “Study terminated due to lack of enrolment..” (96% match in meaning)
• Sym004 Versus Futuximab or Modotuximab in Patients With mCRC
  “Study was terminated due to administrative reasons” (87% match in meaning)
• Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
  “The study was terminated early due to futility of enrolment and not for safety reasons.” (85% match in meaning)
• A Phase IV Study in Subjects With Neurogenic Orthostatic Hypotension
  “Study was terminated due to poor enrollment” (85% match in meaning)
• Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer
  “Study was terminated due to lack of accrual” (84% 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.