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NCT00637923 · ClinicalTrials.gov registry record · Phase 2

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

A Phase 2 study, sponsored by Romark Laboratories L.C..

Completed
Registry status
Phase 2
Development phase
112
Enrollment target

NCT00637923: Completed Phase 2 study, sponsored by Romark Laboratories L.C..

NCT00637923 is a Phase 2 study that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00637923, a Phase 2 study, has completed, sponsored by Romark Laboratories L.C..

COMPLETED
Registry status
Phase 2
Development phase
112 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 treatment-naive patients.

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

FieldValue
Enrollment Target 112 participants
Start Date 2008-03
Est. Completion 2010-04
Phase Phase 2
Romark Laboratories L.C.

16 total trials

What the finished NCT00637923 record still lists

NCT00637923 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00637923 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00637923 about?

NCT00637923 is a clinical study titled "Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients". 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 treatment-naive patients.

What is the current status of trial NCT00637923?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2008-03. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00637923?

The interventions under investigation include: Placebo (DRUG), Ribavirin (DRUG), Nitazoxanide (DRUG), Peginterferon alfa-2a (BIOLOGICAL).

Who is sponsoring clinical trial NCT00637923?

This trial is sponsored by Romark Laboratories L.C., which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00637923's enrollment target sits among peer trials

112 631st of 2000 higher than 1,369 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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Source: ClinicalTrials.gov NCT00637923, the US trial registry maintained by the National Library of Medicine. NCT00637923 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.