Autopsy report · NCT01528930

Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

“Although this study was approved at the Institutional Review Board, Korea Food \& Drug Administration (KFDA) did not approve this study due to safety concern.”

The sponsor’s own words in the registry.

Life of this trial

• Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.

Vital statistics

Status

Withdrawn

Phase

Phase 2

Sponsor

Samsung Medical Center

Sponsor type

University, hospital or other

Conditions

Pulmonary Non-tuberculous Mycobacterial Lung Disease

Interventions

Amikacin

Participants

0

Sites

1

Countries

South Korea

Trials that died the same way

• A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)
  “This study was terminated due to limited efficacy and not due to safety reasons” (60% match in meaning)
• Iontophoresis in Psoriasis
  “FDA did not provide approval of the use of the drug for the study” (60% match in meaning)
• Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
  “This study was terminated for reasons not related to efficacy or safety” (59% match in meaning)
• A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
  “The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.” (58% match in meaning)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
  “The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.” (58% 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.