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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00255177
The ClinicalTrials.gov registry entry for NCT00255177 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VGX Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00255177 reports 0 study locations.
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.
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