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NCT00107653 · ClinicalTrials.gov registry record · Phase 4

Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

A Phase 4 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
569
Enrollment target

NCT00107653 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 569 participants.

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The verdict

NCT00107653, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
569 participants
Enrollment target

Study Summary

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

Interventions

  • DRUG Ribavirin
  • DRUG Peginterferon alfa-2a

Trial Details

FieldValue
Enrollment Target 569 participants
Start Date 2004-10
Est. Completion 2007-09
Phase Phase 4

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT00107653

The ClinicalTrials.gov registry entry for NCT00107653 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 569 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.

NCT00107653 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00107653 about?

NCT00107653 is a clinical study titled "Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.". This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months...

What is the current status of trial NCT00107653?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 569 participants. The study started on 2004-10. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00107653?

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

Who is sponsoring clinical trial NCT00107653?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.