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NCT00255177 · ClinicalTrials.gov registry record · Phase 2
Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients
A Phase 2 study, sponsored by VGX Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00255177: Completed Phase 2 study, sponsored by VGX Pharmaceuticals.
NCT00255177 is a Phase 2 study that has completed, run by VGX Pharmaceuticals. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00255177, a Phase 2 study, has completed, sponsored by VGX Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Hepatitis C virus (HCV) infects approximately 170 million people worldwide. The current standard- of- care therapy of chronic HCV infection is a regimen of subcutaneously administered (pegylated)-interferon-α and ribavirin for 24 weeks (for genotypes 2 and 3) to 48 weeks (for genotype 1). The sustained viral response rates (SVR) in patients infected with genotypes 2 and 3 are \~80% but remain \<50% in patients infected with genotype 1. The treatment is quite toxic with approximately 30% of patients experiencing adverse events (i.e. depression, fever, anemia, fatigue) requiring dose reduction or discontinuation of therapy. This regimen is contraindicated in women who are pregnant and in patients with decompensated liver disease. The absence of acceptable therapies for many patients with HCV infections makes new therapies desirable for this disease.
Primary Outcome
Mean log change in HCV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint
Interventions
- DRUG Placebo
- DRUG VGX-410 (Mifepristone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
What the finished NCT00255177 record still lists
NCT00255177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00255177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00255177 about?
NCT00255177 is a clinical study titled "Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients". Hepatitis C virus (HCV) infects approximately 170 million people worldwide. The current standard- of- care therapy of chronic HCV infection is a regimen of subcutaneously administered (pegylated)-interferon-α and ribavirin for 24 weeks (for genotypes 2 and 3) to 48 weeks (for genotype 1). The sustai...
What is the current status of trial NCT00255177?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2005-11. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00255177?
The interventions under investigation include: Placebo (DRUG), VGX-410 (Mifepristone) (DRUG).
Who is sponsoring clinical trial NCT00255177?
This trial is sponsored by VGX Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00255177's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 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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