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NCT01387932 · ClinicalTrials.gov registry record · Phase 3
HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer
A Phase 3 study, sponsored by Merit Medical Systems.
- Terminated
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
NCT01387932: Clinical Trial Phase 3 study, sponsored by Merit Medical Systems.
NCT01387932 is a Phase 3 study that was terminated before completion, run by Merit Medical Systems. The registered enrollment target is 235 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01387932, a Phase 3 study, was terminated before completion, sponsored by Merit Medical Systems.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and doxorubicin.
Primary Outcome
Median overall survival will be calculated using the Intent-to-Treat (ITT) population in each treatment arm when the last subject has completed two years of follow up after their first study TACE procedure. Per protocol, study subjects were followed for survival until death or deemed lost to follow up. All deaths are reported within safety.
Interventions
- DEVICE HepaSphere/QuadraSphere Microspheres
- PROCEDURE PVA, lipiodol, doxorubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2011-06 |
| Est. Completion | 2021-02 |
| Phase | Phase 3 |
Why NCT01387932 stopped before completion
NCT01387932 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which HepaSphere/QuadraSphere Microspheres is the first listed.
NCT01387932 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01387932 about?
NCT01387932 is a clinical study titled "HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer". The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and ...
What is the current status of trial NCT01387932?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2011-06. Estimated completion is 2021-02.
What interventions are being tested in trial NCT01387932?
The interventions under investigation include: HepaSphere/QuadraSphere Microspheres (DEVICE), PVA, lipiodol, doxorubicin (PROCEDURE).
Who is sponsoring clinical trial NCT01387932?
This trial is sponsored by Merit Medical Systems, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01387932's enrollment target sits among peer trials
235 1296th of 2000 higher than 704 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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