Autopsy report · NCT03099135

A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection

“Recruitment prematurely stopped based on decision to stop HPC program (not due to safety or efficacy results) + On 31 Jan 2018 decision to stop the study”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 10 months before it stopped.
• 24 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Janssen Research & Development, LLC

Sponsor type

Industry

Conditions

Hepatitis C

Interventions

No Treatment

Participants

24

Sites

11

Countries

Canada, New Zealand, Poland, Singapore

Trials that died the same way

• Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
  “Study halted due to low recruitment, unrelated to safety or efficacy reasons” (73% match in meaning)
• Understanding Hemophilia A and B Drug Dosage Administration Patterns
  “Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. See details in Description section.” (72% match in meaning)
• Obesity Hypoventilation Syndrome Prevalence Study
  “This study was stopped due to low recruitment.” (70% match in meaning)
• Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients
  “The study was stopped due to recruitment difficulties” (69% match in meaning)
• Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
  “The study was prematurely halted primarily due to low patient accrual. Despite efforts to optimize recruitment, the enrollment rate remained insufficient to meet the predefined targets, and continuation was deemed unfeasible” (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.