Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients
Public ClinicalTrials.gov record NCT00255177. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-label Phase II Trial of the Anti-HCV Activity and Safety of VGX-410 (Mifepristone) at 3 Dose Levels in HCV Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00255177
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 44 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2005
- Primary completion
- Aug 31, 2007
- Completion
- Dec 31, 2007
- Last update posted
- Nov 2, 2009
2005 – 2008
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Connecticut | Farmington | Connecticut | 06030 | — |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00255177, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2009 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00255177 live on ClinicalTrials.gov.