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NCT00703118 · ClinicalTrials.gov registry record · Phase 3

A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

A Phase 3 study of Hepatitis C, Chronic, sponsored by Tibotec BVBA.

Completed
Registry status
Phase 3
Development phase
663
Enrollment target
20
Study locations

NCT00703118 is a Phase 3 study of Hepatitis C, Chronic that has completed, run by Tibotec BVBA. The registered enrollment target is 663 participants, above the 351-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT00703118, a Phase 3 study of Hepatitis C, Chronic, has completed, sponsored by Tibotec BVBA.

COMPLETED
Registry status
Phase 3
Development phase
663 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

Conditions Studied

Hepatitis C, Chronic

Interventions

  • DRUG Placebo
  • DRUG Ribavirin
  • DRUG Telaprevir
  • DRUG Peg-IFN-alfa-2a

Study Locations (20)

California

  • - Coronado
  • - La Jolla
  • - Los Angeles
  • - San Francisco

Florida

  • - Bradenton
  • - Gainesville
  • - Miami

Massachusetts

  • - Boston
  • - Worcester

Alabama

  • - Birmingham

Colorado

  • - Aurora

Georgia

  • - Atlanta

Indiana

  • - Indianapolis

Maryland

  • - Baltimore

Trial Details

FieldValue
Enrollment Target 663 participants
Start Date 2008-10
Est. Completion 2010-07
Phase Phase 3

Sponsor

Tibotec BVBA

1 total trials

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What the Registry Record Tells You About NCT00703118

The ClinicalTrials.gov registry entry for NCT00703118 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 663 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 351-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (89% higher). The listed sponsor is Tibotec BVBA, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT00703118 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00703118 about?

NCT00703118 is a clinical study titled "A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment". The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

What is the current status of trial NCT00703118?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 663 participants. The study started on 2008-10. Estimated completion is 2010-07.

What conditions does trial NCT00703118 study?

This clinical trial studies the following conditions: Hepatitis C, Chronic.

What interventions are being tested in trial NCT00703118?

The interventions under investigation include: Placebo (DRUG), Ribavirin (DRUG), Telaprevir (DRUG), Peg-IFN-alfa-2a (DRUG).

Who is sponsoring clinical trial NCT00703118?

This trial is sponsored by Tibotec BVBA, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00703118 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.