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NCT00495391 · ClinicalTrials.gov registry record · Phase 2
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C
A Phase 2 study, sponsored by Romark Laboratories L.C..
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT00495391: Completed Phase 2 study, sponsored by Romark Laboratories L.C..
NCT00495391 is a Phase 2 study that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00495391, a Phase 2 study, has completed, sponsored by Romark Laboratories L.C..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that have previously failed to respond to treatment with peginterferon and ribavirin.
Primary Outcome
Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
Interventions
- DRUG Placebo
- DRUG Ribavirin
- DRUG Nitazoxanide
- BIOLOGICAL Peginterferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
What the finished NCT00495391 record still lists
NCT00495391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00495391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00495391 about?
NCT00495391 is a clinical study titled "Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C". The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that have previously failed to respond to treatment with peginterferon and ribavirin.
What is the current status of trial NCT00495391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2007-07. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00495391?
The interventions under investigation include: Placebo (DRUG), Ribavirin (DRUG), Nitazoxanide (DRUG), Peginterferon alfa-2a (BIOLOGICAL).
Who is sponsoring clinical trial NCT00495391?
This trial is sponsored by Romark Laboratories L.C., which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00495391's enrollment target sits among peer trials
64 996th of 2000 higher than 992 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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