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NCT00554372 · ClinicalTrials.gov registry record · Phase 2
A Study of Recombinant Vaccinia Virus to Treat Unresectable Primary Hepatocellular Carcinoma
A Phase 2 study, sponsored by Jennerex Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00554372: Completed Phase 2 study, sponsored by Jennerex Biotherapeutics.
NCT00554372 is a Phase 2 study that has completed, run by Jennerex Biotherapeutics. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00554372, a Phase 2 study, has completed, sponsored by Jennerex Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine the dose to be used in further testing.
Primary Outcome
Proportion of subjects achieving disease control at 8 weeks based on a modified Response Evaluation Criteria in Solid Tumors v1.0 (mRECIST). Per mRECIST for target lesions as assessed by dynamic contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of all tumor(s); Partial Response (PR), \>=30% decrease in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any
Interventions
- GENETIC JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
What the finished NCT00554372 record still lists
NCT00554372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) is the first listed.
NCT00554372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00554372 about?
NCT00554372 is a clinical study titled "A Study of Recombinant Vaccinia Virus to Treat Unresectable Primary Hepatocellular Carcinoma". The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine the dose to be used in further testing.
What is the current status of trial NCT00554372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2008-08. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00554372?
The interventions under investigation include: JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) (GENETIC).
Who is sponsoring clinical trial NCT00554372?
This trial is sponsored by Jennerex Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00554372's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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